A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

Opthea Limited366 enrolled

Overview

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

366

Conditions

Neovascular Age-related Macular Degeneration

Interventions

OPT-302BIOLOGICAL

Intravitreal injection

ranibizumabBIOLOGICAL

Intravitreal injection

sham intravitreal injectionOTHER

Sham (mock) intravitreal injection

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD * An ETDRS BCVA score between 60 and 25 (inclusive) letters Exclusion Criteria: * Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye * Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye * Poorly controlled diabetes mellitus (defined as HbA1c\>7%) * Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study

Locations (108)

Outcomes

Primary Outcomes

Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)