A clinical study of OPT-302 with aflibercept compared to aflibercept 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: EUCTR2020-004694-46-DE
• Lead Sponsor: Opthea Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-09
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD.;Secondary Objective: The secondary objectives of the study are to determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept from Baseline to (and at) Week 52 as determined by:<br>Efficacy:<br>• Changes in ETDRS BCVA letter score<br>• Changes in anatomical parameters (CNV area, CST, SRF and IR cysts)<br>Safety:<br>• Incidence of adverse events (AEs)<br>• Deterioration in ETDRS BCVA letter score<br>• Incidence of anti-OPT-302 antibody (ADA) formation.<br>Pharmacokinetic:<br>• Pharmacokinetic parameters of OPT-302.;Primary end point(s): Mean change from Baseline to Week 52 in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters. ;Timepoint(s) of evaluation of this end point: 52 Weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy<br>• Proportion of participants gaining 15 or more ETDRS BCVA letters from<br>Baseline to Week 52.<br>• Proportion of participants gaining 10 or more ETDRS BCVA letters from<br>Baseline to Week 52.<br>• Change in choroidal neovascularisation (CNV) area by fluorescein<br>angiography (FA) from Baseline to Week 52.<br>• Proportion of participants with absence of both sub-retinal fluid (SRF)<br>and intra-retinal (IR) cysts by spectral domain optical coherence<br>tomography (SD-OCT) at Week 52.<br>Safety:<br>• Incidence of ocular and non-ocular Treatment-Emergent Adverse<br>Events (TEAEs).<br>• Proportion of participants losing 15 or more ETDRS BCVA letters from<br>Baseline to Week 52.<br>• Participant incidence of anti-OPT-302 antibody (ADA) formation.<br>Pharmacokinetic:<br>• OPT-302 pharmacokinetic parameters.;Timepoint(s) of evaluation of this end point: Throughout the course of the study, as defined in the protocol.