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Clinical trial

A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD

ID
Name
OPT-302-1004
Description
A 2-year, phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Trial arms
Trial start
2021-03-12
Estimated PCD
2025-07-01
Trial end
2026-07-01
Status
Recruiting
Phase
Early phase I
Treatment
2.0 mg OPT-302
intravitreal injection
Arms:
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302, 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302
0.5 mg ranibizumab
intravitreal injection
Arms:
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302, 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302, 0.5 mg ranibizumab with sham
Sham
intravitreal injection
Arms:
0.5 mg ranibizumab with sham
Size
990
Primary endpoint
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
Baseline to Week 52
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 990, 'type': 'ESTIMATED'}}
Updated at
2024-03-28

1 organization

2 products

1 indication

Product
OPT-302
Indication
Age-Related Macular Degeneration
Product
Ranibizumab
Organization
Opthea