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.

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

Ranibizumab: Clinical Trial Landscape, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Ranibizumab, a recombinant humanized monoclonal antibody fragment, continues to be a significant therapeutic agent primarily for neovascular age-related macular degeneration (AMD) and other retinal vascular diseases. This report analyzes its current clinical trial activity, market positioning, and projected trajectory.

What are the key therapeutic areas for ranibizumab?

Ranibizumab is indicated for the treatment of:

• Neovascular (wet) age-related macular degeneration (AMD)
• Macular edema following retinal vein occlusion (RVO)
• Diabetic macular edema (DME)
• Diabetic retinopathy (DR)
• Neovascular glaucoma

The drug functions by inhibiting vascular endothelial growth factor A (VEGF-A), a key mediator of angiogenesis and vascular permeability.

What is the current status of ranibizumab's clinical development?

Ranibizumab's clinical development is largely characterized by its established efficacy and ongoing investigations for new indications or improved delivery methods. The majority of active clinical trials focus on biosimilar development and exploring novel administration routes to enhance patient convenience and potentially reduce treatment burden.

Key Areas of Current Clinical Investigation:

• Biosimilar Development: Numerous trials are underway to establish the biosimilarity of ranibizumab variants to the reference product (Lucentis). These trials typically involve pharmacokinetic (PK), pharmacodynamic (PD), immunogenicity, and clinical efficacy assessments.
• Extended Duration Formulations: Research aims to develop sustained-release formulations or drug delivery systems that would reduce the frequency of intravitreal injections, a common requirement for ranibizumab therapy. This includes implantable devices and novel injectable formulations.
• New Indications: While established in its primary indications, exploratory trials may investigate ranibizumab's potential in other VEGF-mediated ocular conditions.

Overview of Ranibizumab Clinical Trials (as of recent data):

Trial Status	Number of Trials	Primary Focus Areas
Recruiting	~15-25	Biosimilar efficacy, safety, novel delivery systems, comparative studies
Active, not recruiting	~10-20	Long-term follow-up of existing studies, post-marketing surveillance
Completed	>100	Established efficacy and safety in primary indications, PK/PD studies, comparative trials
Terminated	<5	Generally due to strategic decisions or lack of significant therapeutic benefit in early phases

Source: Analysis of publicly available clinical trial registries (e.g., ClinicalTrials.gov).

The landscape for ranibizumab is increasingly influenced by the advent of biosimilars. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have specific guidelines for the approval of biosimilar versions of ranibizumab. These approvals hinge on demonstrating no clinically meaningful differences in safety, efficacy, and immunogenicity compared to the reference product.

How does ranibizumab's market perform?

The global market for ranibizumab has been substantial, driven by the high prevalence of retinal diseases, particularly AMD, and the drug's proven clinical outcomes. However, the market is undergoing significant shifts due to biosimilar competition and evolving treatment paradigms.

Market Segmentation and Drivers:

• Geographic Regions: North America, Europe, and Asia-Pacific represent the largest markets, influenced by aging populations and healthcare infrastructure.
• Disease Indications: Wet AMD remains the dominant indication, followed by DME and RVO.
• Drivers:
  • Increasing prevalence of age-related macular degeneration and diabetic retinopathy.
  • Growing awareness and diagnosis rates of ocular diseases.
  • Advancements in diagnostic technologies facilitating early detection.
  • The proven efficacy of anti-VEGF therapies, including ranibizumab.

Market Challenges and Restraints:

• Biosimilar Entry: The introduction of biosimilar versions of ranibizumab is leading to price erosion and increased market fragmentation.
• High Treatment Cost: The ongoing need for repeated intravitreal injections contributes to significant healthcare expenditure.
• Competition from other Anti-VEGF Agents: Bevacizumab, while often used off-label, and aflibercept represent significant competitive forces.
• Development of Novel Therapies: Emerging gene therapies and longer-acting agents pose potential future competition.

Key Market Players (Reference Product and Biosimilars):

• Reference Product:
  • Novartis (Lucentis)
• Biosimilar Developers (examples):
  • Samsung Bioepis
  • Celltrion Healthcare
  • Amneal Pharmaceuticals
  • Viatris
  • Apellis Pharmaceuticals (though primarily known for geographic atrophy treatments, they may be involved in broader anti-VEGF discussions)

Market Size and Growth Projections:

The global ranibizumab market was valued in the billions of U.S. dollars. Post-biosimilarization, the market is expected to experience a compound annual growth rate (CAGR) that is more moderate compared to its pre-biosimilar period, with growth primarily driven by volume expansion in emerging markets and increased adoption of biosimilars. Projections indicate a continued, albeit slower, market expansion through 2030. The overall anti-VEGF market segment, which ranibizumab belongs to, is projected for sustained growth due to the persistent burden of retinal diseases.

Example Projection Trend:

• 2023 Value: Approximately USD 4.0 - 5.0 billion
• 2028 Projected Value: Approximately USD 4.5 - 5.5 billion
• Projected CAGR (2023-2028): 1-3% (influenced by biosimilar price pressure offsetting volume growth)

Sources: Market research reports from various industry analysts, company financial disclosures.

The competitive landscape for ranibizumab is becoming increasingly complex. Biosimilars are expected to capture a significant share of the market, particularly in regions with established biosimilar regulatory pathways and reimbursement policies. This intensified competition is likely to drive down prices, making the treatment more accessible.

What is the future outlook for ranibizumab?

The future outlook for ranibizumab is characterized by a dual trajectory: continued relevance in its established indications, particularly with biosimilar alternatives, and potential expansion through improved delivery systems and formulation advancements.

Key Factors Shaping the Future:

• Biosimilar Dominance: As more ranibizumab biosimilars gain regulatory approval and market penetration, they will likely become the dominant form of the drug used, driving down costs and increasing accessibility.
• Advancements in Drug Delivery: The success of research into longer-acting formulations or implantable devices could significantly alter the treatment paradigm. A reduction in injection frequency would enhance patient adherence and potentially improve long-term outcomes.
• Competition: The sustained threat from other anti-VEGF agents (e.g., aflibercept, bevacizumab) and the emergence of novel therapeutic modalities like gene therapy for retinal diseases will continue to shape ranibizumab's market share.
• Geographic Expansion: While mature markets will be influenced by biosimilar competition, emerging markets may present opportunities for growth, assuming access and affordability improve.
• Real-World Evidence: Ongoing collection and analysis of real-world data will be critical in demonstrating the long-term safety, effectiveness, and cost-effectiveness of both reference ranibizumab and its biosimilars.

Projected Impact of Biosimilars:

The introduction of biosimilars has a demonstrably deflationary effect on the market. For example, post-biosimilarization of other biologics, price reductions of 20-40% within the first few years of market entry are common. This trend is anticipated for ranibizumab, leading to increased patient access and potentially a higher number of treated individuals, even if the overall market value experiences slower growth.

Emerging Technologies:

The development of sustained-release intravitreal injections and long-term implants represents a significant area of innovation. Companies are investing in technologies designed to deliver ranibizumab (or its biosimilars) over periods of six months or longer, reducing the need for frequent office visits and injections. Successful commercialization of such technologies could revitalize the ranibizumab market by addressing a key patient and physician unmet need.

Therapeutic Landscape Evolution:

The field of retinal disease treatment is not static. While ranibizumab and its biosimilars will likely remain important options, ongoing research into gene therapy for conditions like inherited retinal dystrophies and geographic atrophy (GA) could shift treatment paradigms. However, for wet AMD and DME, anti-VEGF therapy, including ranibizumab, is expected to remain a cornerstone for the foreseeable future.

Key Takeaways

Ranibizumab's established efficacy in treating major retinal vascular diseases underpins its continued clinical relevance. The market is characterized by the increasing prominence of biosimilars, which are driving price competition and expanding accessibility. Future growth will be influenced by the success of novel drug delivery systems aimed at reducing injection frequency and ongoing competition from other anti-VEGF therapies and emerging treatment modalities.

Frequently Asked Questions

1. What is the primary mechanism of action for ranibizumab? Ranibizumab inhibits vascular endothelial growth factor A (VEGF-A), a protein that stimulates the growth of abnormal blood vessels and leakage from existing ones in the eye.

2. Which are the main approved indications for ranibizumab? The main indications include neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

3. How will the approval of ranibizumab biosimilars impact its market price? Biosimilar approvals are expected to lead to significant price reductions due to increased market competition.

4. Are there any alternative treatment modalities to ranibizumab for wet AMD? Yes, other anti-VEGF agents such as aflibercept and bevacizumab (often used off-label) are also used. Emerging therapies like gene therapy are also under development for various retinal conditions.

5. What are the current challenges in ranibizumab therapy? The primary challenges include the requirement for frequent intravitreal injections, associated patient discomfort, treatment burden, and the cost of therapy.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Biosimilarity and Interchangeability. Retrieved from https://www.fda.gov/drugs/biosimilars/biosimilarity-and-interchangeability [2] European Medicines Agency. (n.d.). Biosimilar medicines. Retrieved from https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines [3] ClinicalTrials.gov. (n.d.). Ranibizumab clinical trials. Retrieved from https://clinicaltrials.gov/ct2/results?cond=&term=ranibizumab [4] Market research reports on the global ranibizumab market (e.g., from Grand View Research, Mordor Intelligence, IQVIA). Specific reports are proprietary and not publicly accessible for direct citation. [5] Pharmaceutical company investor relations and annual reports (e.g., Novartis, Samsung Bioepis, Celltrion Healthcare). Specific reports are proprietary and not publicly accessible for direct citation.