A clinical study of OPT-302 with ranibizumab compared to ranibizumab alone in patients with neovascular age-related macular degeneratio
- Conditions
- eovascular age-related macular degeneration (wet AMD)MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 27.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-004736-24-DK
- Lead Sponsor
- Opthea Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 990
• 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
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
- 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 0.5 mg ranibizumab, in participants with neovascular AMD.<br>;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 0.5 mg ranibizumab 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 Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters ;Timepoint(s) of evaluation of this end point: Week 52
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy:<br>• Proportion of participants gaining 15 or more ETDRS BCVA letters from Baseline to Week 52<br>• Proportion of participants gaining 10 or more ETDRS BCVA letters from Baseline to Week 52<br>• Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) from Baseline to Week 52<br>• Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by spectral domain optical coherence tomography (SD-OCT) at Week 52<br>Safety:<br>•Incidence of ocular and non-ocular Treatment-Emergent Adverse Events (TEAEs)<br>• Proportion of participants losing 15 or more ETDRS BCVA letters from 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.