CLINICAL TRIALS PROFILE FOR LUCENTIS
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Biosimilar Clinical Trials for LUCENTIS
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for LUCENTIS
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00284089 ↗ | Safety and Efficacy of Ranibizumab in Japanese Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration | Completed | Novartis | Phase 1/Phase 2 | 2005-04-01 | Open-label Multicenter, Phase I/II Study comprising three phases (single dose, multiple dose and extension phase), Assessing the Safety and Efficacy of Ranibizumab (RFB002) in Japanese Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD). |
| NCT00344227 ↗ | Prospective OCT Study With Lucentis for Neovascular AMD (PrONTO Study) | Completed | Genentech, Inc. | Phase 2 | 2004-08-01 | The PrONTO Study was designed to evaluate the response of neovascular age-related macular degeneration (AMD) patients to intravitreal Lucentis using Optical Coherence Tomography (OCT) imaging. OCT was then used to determine the need for retreatment after 3 monthly injections of Lucentis. Patients would be followed for 2 years. |
| NCT00344227 ↗ | Prospective OCT Study With Lucentis for Neovascular AMD (PrONTO Study) | Completed | University of Miami | Phase 2 | 2004-08-01 | The PrONTO Study was designed to evaluate the response of neovascular age-related macular degeneration (AMD) patients to intravitreal Lucentis using Optical Coherence Tomography (OCT) imaging. OCT was then used to determine the need for retreatment after 3 monthly injections of Lucentis. Patients would be followed for 2 years. |
| NCT00363168 ↗ | Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial | Completed | Genentech, Inc. | Phase 1 | 2006-08-01 | This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration. A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition. |
| NCT00363168 ↗ | Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial | Completed | Johns Hopkins University | Phase 1 | 2006-08-01 | This research is being done to look at the effects of an experimental drug, ranibizumab, on a condition called "predominantly hemorrhagic subfoveal choroidal neovascularization (CNV)" due to wet age-related macular degeneration. A predominantly hemorrhagic CNV lesion is diagnosed when at least 50% of the choroidal neovascular lesion is occupied by blood under the retina. We want to find out if injections of ranibizumab into the eye will help patients with this condition. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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