CLINICAL TRIALS PROFILE FOR RANIBIZUMAB

Biosimilar Clinical Trials for ranibizumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02121353 ↗	Safety Study of PF582 Versus Lucentis in Patients With Age Related Macular Degeneration	Completed	Pfenex, Inc	Phase 1/Phase 2	2013-11-01	The aim of this study is to test if PF582 (ranibizumab) is safe and similar to Lucentis (ranibizumab). Participants will have a screening visit to check for eligibility. Eligible participants will receive either PF582 or Lucentis, by injection into one eye on study Day 1, 28 and 56. Visits will be conducted on Day 2, 7, 14 80 and at 6 and 12 months. During the study participants will undergo the following procedures: height, weight and vital signs (blood pressure, pulse, temperature, breathing rate) measurement; medical and surgical history and concomitant medications; adverse event monitoring; physical examinations; eye tests (reading chart, measurement of retinal thickness [via pictures of the retina] and examination of the eye's blood vessels, via pictures taken following injection of a dye into the arm), blood collection and a urine pregnancy test, where applicable.
NCT03150589 ↗	A Study to Compare SB11 (Proposed Ranibizumab Biosimilar) to Lucentis in Subjects With Neovascular Age-related Macular Degeneration (AMD)	Completed	Samsung Bioepis Co., Ltd.	Phase 3	2018-03-14	This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.
NCT06985706 ↗	Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser for Treating Severe Diabetic Macular Oedema When the Central Retina Goes	RECRUITING	Queen's University, Belfast	PHASE3	2025-05-19	The macula is the centre of the retina; it gives central sight, colour and fine detail. People with diabetes may develop diabetic macular oedema (DMO). In DMO, fluid leaks from blood vessels and builds up at the macula, causing sight loss. DMO can be mild or severe; this is determined by measuring, in microns (m), how thick the macula is. One m is one-thousandth of a millimetre. People presenting with mild DMO (macula less than 400 m thick; normally it is around 250 m but varies with sex and ethnicity) are offered macular laser treatment. Laser works well for these patients. Subthreshold micropulse laser (SML), which does not damage the macula, works as well as standard laser, which produces a burn, and is cost-effective. However, many people present with severe DMO (macula 400 m or thicker) where the laser does not work well. The standard treatment is eye injections of anti-VEGFs. VEGF stands for vascular endothelial growth factor. VEGF is high in eyes with DMO and causes blood vessel leakage. Anti-VEGFs block VEGF. They are given monthly to begin with, then every 2-3 months for months or years until DMO clears. In many patients DMO comes back after clearing and anti-VEGFs need to be re-started most often monthly initially again. To improve the care of people with severe DMO this study will compare the current standard care (anti-VEGFs alone) with a strategy in which patients begin with an anti-VEGF but switch to SML once the macula is less than 400 m thick. Patients aged over 18 years with type 1 or type 2 diabetes and severe DMO can participate. They are randomly allocated either anti-VEGFs alone or anti-VEGFs then SML when the macula is less than 400 m thick.
NCT06985706 ↗	Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser for Treating Severe Diabetic Macular Oedema When the Central Retina Goes	RECRUITING	Belfast Health and Social Care Trust	PHASE3	2025-05-19	The macula is the centre of the retina; it gives central sight, colour and fine detail. People with diabetes may develop diabetic macular oedema (DMO). In DMO, fluid leaks from blood vessels and builds up at the macula, causing sight loss. DMO can be mild or severe; this is determined by measuring, in microns (m), how thick the macula is. One m is one-thousandth of a millimetre. People presenting with mild DMO (macula less than 400 m thick; normally it is around 250 m but varies with sex and ethnicity) are offered macular laser treatment. Laser works well for these patients. Subthreshold micropulse laser (SML), which does not damage the macula, works as well as standard laser, which produces a burn, and is cost-effective. However, many people present with severe DMO (macula 400 m or thicker) where the laser does not work well. The standard treatment is eye injections of anti-VEGFs. VEGF stands for vascular endothelial growth factor. VEGF is high in eyes with DMO and causes blood vessel leakage. Anti-VEGFs block VEGF. They are given monthly to begin with, then every 2-3 months for months or years until DMO clears. In many patients DMO comes back after clearing and anti-VEGFs need to be re-started most often monthly initially again. To improve the care of people with severe DMO this study will compare the current standard care (anti-VEGFs alone) with a strategy in which patients begin with an anti-VEGF but switch to SML once the macula is less than 400 m thick. Patients aged over 18 years with type 1 or type 2 diabetes and severe DMO can participate. They are randomly allocated either anti-VEGFs alone or anti-VEGFs then SML when the macula is less than 400 m thick.

All Clinical Trials for ranibizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00056836 ↗	A Study to Evaluate rhuFab V2 in Subjects With Minimally Classic or Occult Subfoveal Neovascular Macular Degeneration	Completed	Genentech, Inc.	Phase 3	2003-03-01	The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.
NCT00061594 ↗	A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration	Completed	Genentech, Inc.	Phase 3	2003-05-01	This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.
NCT00089765 ↗	Ranibizumab Injections to Treat Retinal Tumors in Patients With Von Hippel-Lindau Syndrome	Completed	National Eye Institute (NEI)	Phase 1	2004-08-10	This study will examine whether he drug ranibizumab can slow or stop the growth of angiomas (blood vessel tumors) in patients with Von Hippel-Lindau syndrome (VHL). Angiomas commonly develop in the back of the eye on the retina and the optic nerve in patients with VHL. Although these tumors are not cancerous, they may cause significant vision loss. Current treatments, including laser therapy, cryotherapy, and vitrectomy, may not be successful or possible for all patients. Ranibizumab decreases production of VEGF, a growth factor that is important for the formation of new blood vessels and that is elevated in patients with VHL. Preliminary findings from other studies suggest that ranibizumab can reduce retinal thickening caused by vessel and tumor growth and improve vision. Patients 18 years of age and older with retinal angiomas due to VHL in one or both eyes and central vision loss of 20/40 or worse may be eligible for this study. Participants undergo the following tests and procedures: - Medical history, physical examination, electrocardiogram (EKG) and blood tests. - Eye examination, including eye pressure measurement and dilation of the pupils to examine the retina. - Fluorescein angiography to evaluate the eye's blood vessels. For this test, a yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Optical coherence tomography to measure retinal thickness. The eyes are examined through a machine that produces cross-sectional pictures of the retina. These measures are repeated during the study to determine changes, if any, in retinal thickening. - Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to examine and photograph the back of the eye. - Electroretinogram (ERG) to measure electrical responses generated from within the retina. For this test, the patient sits in a dark room for 30 minutes with his or her eyes patched. Then, a small silver disk electrode is taped to the forehead, the eye patches are removed, the surface of the eye is numbed with eye drops, and contact lenses are placed on the eyes. The patient looks inside an open white globe that emits a series of light flashes for about 20 minutes. The contact lenses sense small electrical signals generated by the retina when the light flashes. - Ranibizumab injections to treat ocular angiomas. Ranibizumab is injected through a needle into the eye's vitreous (gel-like substance that fills the inside of the eye). Seven injections are given over a 28-week period. Before each injection, the surface of the eye is numbed with anesthetic eye drops. This is followed by injection of another anesthetic into the lower portion of the eye in the clear tissue surrounding the white of the eye. After a few minutes, the ranibizumab is injected into the vitreous. Patients receive ranibizumab injections at the first visit (during enrollment) and again at 4, 8, 12, 16, 20 and 24 weeks after the first injection. At the 28-week visit, the doctor will determine if further treatment is needed. Patients can continue to have injections every 4 weeks until 1 year of follow-up (54 weeks). At each injection visit, participants repeat most of the tests described above to evaluate the response to treatment and return a week later for another eye examination.
NCT00090623 ↗	A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)	Completed	Genentech, Inc.	Phase 3	2004-08-01	This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
NCT00095433 ↗	Extension Study of rhuFab V2 in Subjects With Neovascular Age-Related Macular Degeneration (AMD)	Completed	Genentech, Inc.	Phase 3	2002-09-01	This is a Phase III, open-label, multicenter extension study of intravitreally administered ranibizumab in subjects with primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to AMD who have completed the treatment phase of a Genentech sponsored Phase I or Phase I/II ranibizumab protocol (FVF1770g, FVF2128g, or FVF2425g).
NCT00138632 ↗	Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)	Completed	Novartis	Phase 1/Phase 2	2005-09-01	This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily. It also explores the efficacy of the compound in patients with wet age-related macular edema. In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the current standard of care for AMD. As a result, ranibizumab is the active control for Cohort 2.
NCT00251459 ↗	A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)	Completed	Genentech, Inc.	Phase 3	2005-11-01	This is a Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to AMD.

Clinical Trial Conditions for ranibizumab

Condition Name

Condition Name for ranibizumab
Intervention	Trials
Diabetic Macular Edema	87
Age-related Macular Degeneration	49
Macular Edema	45
Macular Degeneration	44

Condition MeSH

Condition MeSH for ranibizumab
Intervention	Trials
Macular Degeneration	218
Macular Edema	173
Edema	133
Wet Macular Degeneration	77

Clinical Trial Locations for ranibizumab

Trials by Country

Trials by Country for ranibizumab
Location	Trials
Italy	180
United Kingdom	154
Japan	134
China	131
Canada	94

Trials by US State

Trials by US State for ranibizumab
Location	Trials
California	92
Texas	77
Florida	64
Maryland	61
New York	54

Clinical Trial Progress for ranibizumab

Clinical Trial Phase

Clinical Trial Phase for ranibizumab
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	6
PHASE2	2

Clinical Trial Status

Clinical Trial Status for ranibizumab
Clinical Trial Phase	Trials
Completed	335
Unknown status	74
Recruiting	39

Clinical Trial Sponsors for ranibizumab

Sponsor Name

Sponsor Name for ranibizumab
Sponsor	Trials
Genentech, Inc.	109
Novartis Pharmaceuticals	54
Novartis	41

Sponsor Type

Sponsor Type for ranibizumab
Sponsor	Trials
Other	535
Industry	333
NIH	23

Last updated: May 21, 2026

Ranibizumab clinical trials update, market analysis and forecast (2026-2036)

Ranibizumab (Lucentis, Genentech/Roche) remains a core ophthalmology anti-VEGF franchise in retinal diseases. The market is shaped by (1) contract-driven uptake vs other anti-VEGF agents, (2) biosimilar and “interchangeability-equivalent” dynamics in the EU, and (3) next-generation ophthalmic delivery programs targeting reduced dosing burden. Near-term growth is constrained by aging-linked incidence trends and pricing pressure, but unit volumes stay resilient in center-based retina care. Patent exclusivity and biosimilar readiness in key markets drive timing risk, while clinical trial pipelines and real-world dosing patterns determine how quickly clinicians shift away from q4-q6 week regimens.

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What is the latest clinical trial status for ranibizumab in retinal diseases (2024-2026)?

Latest status snapshot (high level)

• Ranibizumab continues to be studied in incremental label expansions and comparative-effectiveness studies, with the strongest focus in diabetic macular edema (DME), age-related macular degeneration (AMD) (wet), and retinal vein occlusion (RVO).
• Most “new” ranibizumab activity clusters around:
  1. dosing strategy optimization (treat-and-extend, extended intervals),
  2. combination regimens (with adjunct laser or steroid where applicable),
  3. real-world outcomes and imaging biomarkers for visual acuity response,
  4. comparative trials versus aflibercept and faricimab, where ranibizumab functions as an active comparator.

How trial outcomes translate into market share

• Retina prescribing is highly sensitive to dosing interval and clinic workflow.
• Even when efficacy is similar, adoption tends to follow products that reduce injection frequency and improve predictability of treat-and-extend schedules.

Which retinal indications still drive ranibizumab trials and evidence updates?

AMD (wet)

• Goal: refine retreatment intervals and identify responders for extended dosing.
• Competitive context: faricimab and aflibercept maintain pressure through longer intervals in many protocols.

DME

• Goal: optimize combination/sequence strategies in populations with varying baseline thickness and prior anti-VEGF exposure.
• Clinical adoption is driven by reduction in visit burden and durability of vision gains.

RVO (BRVO/CRVO)

• Goal: improve dosing efficiency and assess adjunct endpoints tied to retinal anatomy.
• This segment can show faster uptake of agents with simpler long-interval regimens.

What trial endpoints matter most for payer and provider adoption?

• Mean change in BCVA (ETDRS letters).
• Proportion achieving predefined vision thresholds (in some programs).
• Injection frequency over fixed follow-up.
• Anatomical correlates: CST reduction and fluid persistence metrics.
• Retreatment criteria sensitivity, especially for treat-and-extend.

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Are there new ranibizumab biosimilar launches or interchange updates affecting trial and market uptake?

Featured market mechanism

• In the EU/UK and other jurisdictions with biosimilar pathways, market share shifts correlate with:
  • formulary positioning,
  • switching protocols,
  • pharmacy benefit manager (PBM) and hospital tender outcomes,
  • clinician comfort and safety/efficacy continuity evidence.

Practical consequence

• Even without major new clinical outcomes, the “effective differentiation” becomes pricing and operational dosing patterns more than headline efficacy.

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How big is the ranibizumab market and what sales are at risk from competitive anti-VEGF substitution?

Commercial base case

• Ranibizumab competes in a large anti-VEGF retinal market driven by AMD, DME, and RVO.
• Growth is limited by:
  • substitution to longer-interval competitors,
  • biosimilar penetration dynamics,
  • pricing compression through tendering.

Key revenue pressure points

• Loss of share to therapies that allow fewer injections under similar outcomes.
• Erosion in some geographies where biosimilars of ranibizumab or class-level alternatives displace branded portfolios.

Market drivers and constraints

Drivers

• Rising treated population due to aging demographics.
• High unmet need in DME and progressive AMD.
• Clinic workflow improvements using protocols with treat-and-extend.

Constraints

• Pricing pressure under hospital and payer tendering.
• Relative convenience and perceived durability vs longer interval agents.

Where is ranibizumab most defensible commercially?

• Regions and care settings where:
  • treat-and-extend standardization already exists,
  • clinicians have entrenched treatment algorithms,
  • tender policies still favor ranibizumab supply continuity or locally priced biosimilar equivalents.

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When does ranibizumab lose exclusivity in major markets?

Exclusivity timeline is jurisdiction- and product-specific

• Ranibizumab exclusivity is determined by the interaction of:
  • patents covering drug substance, formulations, and methods of use,
  • regulatory exclusivities (where applicable),
  • market authorization and supplementary protection certificates (SPCs).

What matters operationally for launch timing

• Biosimilar entry windows often align with:
  • expiration of key composition/formulation patents,
  • expiration of method-of-use claims tied to major indications,
  • resolution of patent disputes and any settlement-driven “carve-out” dates.

(A complete, accurate jurisdiction-by-jurisdiction exclusivity grid requires Orange Book and EU patent/SPC mapping by product form and filing numbers. Without a specific label/regulatory listing reference, an exclusivity forecast risks being incomplete.)

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What patents protect ranibizumab and how does the patent estate influence biosimilar entry risk?

Patent estate categories that typically gate biosimilar entry

• Composition of matter (active ingredient).
• Formulation patents (stability, concentration, buffer system).
• Device and administration related claims (presentation, packaging).
• Methods of use (treatment of AMD, DME, RVO under defined dosing paradigms).
• Manufacturing process patents (cell line, purification, formulation fill-finish steps).

How to interpret patent-driven launch timing in anti-VEGF biosimilars

• For biosimilars, disputes can center on:
  • claim scope overlap between reference product and biosimilar formulation,
  • process differences and whether they avoid infringing steps,
  • design-around of dosing regimens.

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What is the Orange Book status of ranibizumab in the US?

Ranibizumab is not a small-molecule drug and is approved as a biologic. US exclusivity and patent status are typically tracked via FDA biologics listings and patent registries for biologics (not the standard Orange Book small-molecule format alone). A usable “Orange Book status” requires the specific US reference product and registrant patent list.

(Without the specific FDA listing identifier and the patent list, a definitive status statement cannot be produced.)

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Which biosimilar and competitive products affect ranibizumab share most (US, EU, UK)?

Therapeutic class substitution

• Anti-VEGF alternatives used in retinal diseases include:
  • aflibercept,
  • faricimab,
  • and biosimilars within ranibizumab or aflibercept where approvals exist.

Competitive “adoption lever”

• Extended dosing regimens and clinic throughput matter more than incremental efficacy differences when endpoints are close.

How does ranibizumab compare with aflibercept and faricimab on market uptake?

• In general:
  • Products perceived to support longer injection intervals gain formulary/payer preference when clinical outcomes are similar.
  • Ranibizumab remains a standard-of-care option with mature prescribing patterns, but share growth is challenged by longer-interval competitors.

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How do treat-and-extend dosing patterns in clinical evidence affect ranibizumab revenue forecasts?

Core adoption issue

• Treat-and-extend protocols aim to reduce injection frequency while maintaining visual outcomes.
• Revenue projections depend on:
  • baseline patient mix and clinic adherence,
  • time-to-extension and proportion achieving longer intervals,
  • retreatment criteria and imaging thresholds.

What endpoints link to dosing durability assumptions for forecasting?

• Median time to stable extension interval.
• Proportion treated on less frequent schedules after initial loading.
• Mean number of injections per patient-year.

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What regulatory milestones and label updates could change ranibizumab utilization?

Regulatory utilization levers

• Label expansions for subpopulations.
• Updates tied to dosing flexibility or retreatment criteria.
• Safety labeling updates that alter clinic comfort with switching.

Market effect

• New label language can accelerate adoption by reducing off-label use friction, but in retina the dominant impact usually comes from trial-defined injection schedules and payer policy.

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What generic entry risks exist for ranibizumab in the US and EU?

Key risk concept

• For biologics, “generic” is not the direct category; the practical risk is biosimilar entry and switching.
• Litigation and interchange policy determine whether entry turns into rapid share loss or slower adoption.

What to watch for when modeling biosimilar share gains

• Hospital tender award frequency and contract durations.
• Evidence generation supporting interchange or substitution.
• Manufacturer commercialization intensity in key retina centers.

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What patent litigation or settlements could delay biosimilar competition for ranibizumab?

Litigation risk affects two things:

1. whether the biosimilar can launch,
2. when switching from the reference to the biosimilar accelerates.

A precise listing of ranibizumab-specific litigations and settlement-driven “launch-at-risk vs launch-at-agreement” dates requires docket-level mapping to specific reference products and biosimilar filers.

(No complete, accurate litigation calendar can be provided without the referenced patent numbers, court dockets, and settlement dates.)

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Market projection: what scenarios matter most for ranibizumab through 2036?

Scenario framework for a working projection

• Base case: stable retina volumes, modest unit growth, pricing pressure offsets volume growth.
• Downside: accelerated substitution to longer-interval agents plus higher biosimilar share in key geographies.
• Upside: improved dosing durability evidence, sustained formulary position, and slower competitive penetration due to contract lock-ins.

Model inputs that usually dominate the forecast

• Treated prevalence in AMD, DME, RVO.
• Anti-VEGF per-patient injection frequency (by regimen).
• Market share by agent class and by geography.
• Net price after rebates, tenders, and contract rebates.
• Biosimilar penetration curves and switching lag.

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Key takeaways

• Ranibizumab’s near- to mid-term outlook is driven less by new efficacy breakthroughs and more by dosing efficiency, clinic workflow adoption, and substitution to longer-interval anti-VEGF competitors.
• Clinical evidence that improves treat-and-extend durability directly affects injection frequency assumptions used in revenue modeling.
• Patent and regulatory timelines determine biosimilar entry timing, but an accurate exclusivity and litigation calendar requires product- and jurisdiction-specific patent registry mapping.

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FAQs

1. How does ranibizumab’s treat-and-extend dosing frequency compare with faricimab in real-world retinal clinics?
2. Which retinal indication (wet AMD, DME, or RVO) typically produces the highest injection burden for ranibizumab forecasting?
3. How do EU hospital tender cycles influence switching from branded ranibizumab to biosimilar ranibizumab equivalents?
4. What biomarkers in ranibizumab studies most correlate with long-interval extension in DME and AMD?
5. How do payer prior authorization rules change patient access to ranibizumab versus longer-interval anti-VEGF agents?

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References

(No sources were provided for this request; no citations are included.)