A clinical study of OPT-302 with ranibizumab compared to ranibizumab alone in patients with neovascular age-related macular degeneratio

Phase 1

• Conditions: eovascular age-related macular degeneration (wet AMD); MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 27.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-004736-24-DE
• Lead Sponsor: Opthea Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-19
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 990

Inclusion Criteria

• Male or female participants at least 50 years of age.
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 890

Exclusion Criteria

Study Eye:
• Any previous treatment for neovascular AMD.
• Clinically significant ocular disorders (other than neovascular AMD), which may, in the investigator’s opinion, 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.

Note: other protocol exclusion criteria may also apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified