CLINICAL TRIALS PROFILE FOR LUCENTIS

Biosimilar Clinical Trials for LUCENTIS

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

All Clinical Trials for LUCENTIS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for LUCENTIS

Condition Name

Condition Name for LUCENTIS
Intervention	Trials
Diabetic Macular Edema	51
Age-related Macular Degeneration	47
Macular Edema	28
Macular Degeneration	27

Condition MeSH

Condition MeSH for LUCENTIS
Intervention	Trials
Macular Degeneration	157
Macular Edema	106
Edema	82
Wet Macular Degeneration	52

Clinical Trial Locations for LUCENTIS

Trials by Country

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−

Trials by Country for LUCENTIS
Location	Trials
United States	747
China	90
United Kingdom	49
Canada	39
India	32

Trials by US State

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−

Trials by US State for LUCENTIS
Location	Trials
California	59
Texas	51
Florida	42
New York	33
Maryland	31

Clinical Trial Progress for LUCENTIS

Clinical Trial Phase

Clinical Trial Phase for LUCENTIS
Clinical Trial Phase	Trials
Phase 4	68
Phase 3	61
Phase 2/Phase 3	18

Clinical Trial Status

Clinical Trial Status for LUCENTIS
Clinical Trial Phase	Trials
Completed	217
Unknown status	48
Terminated	27

Clinical Trial Sponsors for LUCENTIS

Sponsor Name

Sponsor Name for LUCENTIS
Sponsor	Trials
Genentech, Inc.	79
Novartis Pharmaceuticals	29
Novartis	25

Sponsor Type

Sponsor Type for LUCENTIS
Sponsor	Trials
Other	332
Industry	221
NIH	9

Clinical Trials, Market Analysis, and Projections for Lucentis

Introduction to Lucentis

Lucentis, also known as ranibizumab, is a monoclonal antibody fragment designed for intravitreal injection. It is used to treat various eye conditions, including diabetic retinopathy (DR), diabetic macular edema (DME), and wet age-related macular degeneration (wAMD).

Clinical Trials Overview

Diabetic Retinopathy and Diabetic Macular Edema

The efficacy and safety of Lucentis in treating DR and DME have been evaluated in several clinical trials. The RISE and RIDE studies, which were methodologically identical, randomized, double-masked, sham injection–controlled Phase III trials, involved 759 patients. These studies assessed the efficacy of Lucentis 0.3 mg and 0.5 mg administered monthly to patients with DR and DME. The primary outcome was the proportion of patients gaining ≥15 letters in visual acuity at 2 years, which was sustained at 3 years[1].

Wet Age-Related Macular Degeneration

For wAMD, the VIEW 1 and 2 trials were pivotal. These were randomized, double-masked, active treatment–controlled studies comparing Lucentis 0.5 mg monthly with aflibercept 2.0 mg monthly or every 8 weeks. The primary outcome was the maintenance of vision at 52 weeks, defined as losing <15 ETDRS letters from baseline. Lucentis demonstrated noninferiority to aflibercept in maintaining vision[4].

Key Clinical Trial Findings

• Vision Gains: In the RISE and RIDE trials, a significant proportion of patients treated with Lucentis gained ≥15 letters in visual acuity at 2 years, with these gains sustained at 3 years[1].
• Dosing and Retreatment: Patients in the VIEW 1 and 2 trials received Lucentis 0.5 mg monthly for the first 52 weeks, followed by dosing at least every 12 weeks with additional doses as needed. The average number of injections with Lucentis in the pooled analysis was 4.7 over the 2-year period[4].
• Adverse Reactions: Common adverse reactions in Lucentis-treated patients included conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure, and intraocular inflammation. Serious adverse events such as nonfatal myocardial infarction, nonfatal stroke, and vascular death were also reported, although at low frequencies[4].

Market Analysis

Current Market Size and Forecast

The global market for Lucentis was estimated to be worth US$ 562 million in 2023 and is forecasted to grow to US$ 933.1 million by 2030, with a compound annual growth rate (CAGR) of 8.0% during the forecast period of 2024-2030[2].

Market Players

The main players in the Lucentis market are Roche and Novartis. These companies are actively involved in research and development activities to maintain and expand their market share[2].

Regional Market

The market for Lucentis is analyzed across several major regions, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Each region has its own forecasted sales data from 2023 to 2032, providing a comprehensive view of the global market[5].

Market Projections

Growth Factors and Trends

The market for Lucentis is expected to grow due to several factors, including extensive research in diabetic retinopathy, incremental healthcare spending, and the development of novel therapeutic approaches. However, emerging therapies and new market entrants, such as OPT-302 in combination with Lucentis, are expected to provide significant competition in the future[3][5].

Competitive Landscape

The competitive landscape for Lucentis includes other anti-VEGF agents like aflibercept. The VIEW 1 and 2 trials demonstrated that Lucentis is noninferior to aflibercept in maintaining vision in wAMD patients. New drugs and combination therapies, such as OPT-302, are being developed to challenge the market dominance of Lucentis[3][4].

Regulatory and Development Activities

Lucentis has undergone various regulatory milestones and developmental activities. The drug has been approved for multiple indications, and ongoing research focuses on optimizing treatment protocols and exploring new applications. The patent expiry timeline and other regulatory factors are closely monitored to assess their impact on the market[5].

Emerging Therapies and Competition

OPT-302 and Other Emerging Therapies

OPT-302, developed by Opthea, is being tested in combination with Lucentis for the treatment of wAMD. Phase 3 studies are ongoing, with positive data reported in Phase 2b trials. The consensus revenue estimates project OPT-302 sales of $397.2 million in the US by 2029, adjusted for risk[3].

Impact on Lucentis Market

The launch of late-stage emerging therapies is expected to significantly impact the Lucentis market. These new therapies focus on novel approaches to treat and improve disease conditions, posing a challenge to Lucentis's market dominance. However, Lucentis remains a strong player due to its established efficacy and safety profile[5].

Key Takeaways

• Clinical Efficacy: Lucentis has demonstrated significant efficacy in treating DR, DME, and wAMD, with sustained vision gains over multiple years.
• Market Growth: The global market for Lucentis is projected to grow from US$ 562 million in 2023 to US$ 933.1 million by 2030.
• Competitive Landscape: Lucentis faces competition from other anti-VEGF agents and emerging therapies, which are expected to challenge its market position.
• Regulatory and Development Activities: Ongoing research and regulatory activities are crucial for maintaining and expanding Lucentis's market share.

FAQs

What are the primary indications for Lucentis?

Lucentis is indicated for the treatment of patients with diabetic retinopathy, diabetic macular edema, and wet age-related macular degeneration.

What are the key findings from the RISE and RIDE trials?

The RISE and RIDE trials showed that Lucentis significantly improved visual acuity in patients with DR and DME, with a substantial proportion of patients gaining ≥15 letters in visual acuity at 2 years.

How does Lucentis compare to other anti-VEGF agents in wAMD?

Lucentis has been shown to be noninferior to aflibercept in maintaining vision in wAMD patients, as demonstrated in the VIEW 1 and 2 trials.

What is the forecasted market size for Lucentis by 2030?

The global market for Lucentis is forecasted to reach US$ 933.1 million by 2030, growing at a CAGR of 8.0% from 2024 to 2030.

What emerging therapies are expected to challenge Lucentis's market position?

Emerging therapies such as OPT-302, which is being developed in combination with Lucentis, are expected to provide significant competition in the future.

Sources

1. Clinical Trial Efficacy & Results for DR & DME - Lucentis: https://www.lucentis.com/hcp/dr-dme/efficacy/clinical-trial-results.html
2. Lucentis - Market, Report Size, Worth, Revenue, Growth, Industry: https://reports.valuates.com/market-reports/QYRE-Auto-35H9908/global-lucentis
3. Age Related Macular Degeneration Drug Challenge Market Leader: https://visiblealpha.com/blog/new-wet-amd-drugs-to-challenge-market-leaders-visible-alpha/
4. Clinical Trial Efficacy & Results for wAMD | LUCENTIS® (ranibizumab): https://www.lucentis.com/hcp/wamd/efficacy/clinical-trial-results.html
5. LUCENTIS Market Drug Insight and Market Forecast: https://www.researchandmarkets.com/report/lucentis