OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)

Phase 3

Terminated

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Biological: 2.0 mg OPT-302; Biological: 0.5 mg ranibizumab; Procedure: Sham

• Registration Number: NCT04757610
• Lead Sponsor: Opthea Limited

Brief Summary

A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-17
• Study Start: 2021-03-12
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-06
• Results First Submitted: 2025-06-24
• Results First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Results First Posted: 2025-07-22
• Last Update Posted: 2025-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 986

Inclusion Criteria

• Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
• An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.

Main

Exclusion Criteria

• Any previous treatment for neovascular AMD.

• Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.

• Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

  • additional inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302	0.5 mg ranibizumab	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
0.5 mg ranibizumab with sham	0.5 mg ranibizumab	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.
0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302	2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302	2.0 mg OPT-302	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
0.5 mg ranibizumab with sham	Sham	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302	0.5 mg ranibizumab	0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.

Primary Outcome Measures

Name	Time	Method
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters	Baseline to Week 52	To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)

Secondary Outcome Measures

Name	Time	Method
Participants Gaining 15 or More ETDRS BCVA Letters	Baseline to Week 52	To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52.
Participants Gaining 10 More ETDRS BCVA Letters	Baseline to Week 52	To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 10 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52.
Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)	Baseline to Week 52	To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in CNV area as measured by FA in the study eye from Baseline to Week 52.
Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT	at Week 52	To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT in the study eye at Week 52.

Trial Locations

Locations (4)

ShORe Investigational Site; 🇬🇧 London, United Kingdom

ShORe Investigational site; 🇧🇷 Blumenau, Santa Catarina, Brazil

ShORe Investiagtional Site; 🇺🇸 Poway, California, United States

ShORe Investiagational Site; 🇮🇹 Genova, Italy