Phase 2 N=153 Randomized Quadruple-blind Treatment

A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema

Diabetic Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT03397264 ↗

Enrolled (actual)

153

Serious AEs

7.2%

Results posted

Jun 2022

Primary outcome: Primary: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) — 3; 2; 1; 59 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Aflibercept (Biological); OPT-302 (Biological); Sham intravitreal injection (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Opthea Limited
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	3; 2; 1; 59; 28; 2	—
PRIMARY Phase 2a: Response Rate Defined as Proportion of Participants Receiving OPT-302 With Aflibercept Achieving at Least a 5-letter Gain in BCVA at Week 12	38	—
SECONDARY Mean Change in BCVA	3.0; 5.7; 14.3; 5.9; 6.1	—
SECONDARY Mean Change in CST	-116.0; -41.0; -57.0; -52.2; -34.9	—

Summary

A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.

Eligibility Criteria

Inclusion Criteria

History of diabetic macular edema (DME) ≤ 2 year
Persistent DME despite prior intravitreal anti-VEGF-A therapy with a sub-optimal response
Three or more prior anti-VEGF-A therapy intravitreal injections
EDTRS BCVA score ≤ 73 and ≥ 24 letters

Exclusion Criteria

Ocular disorders or ocular treatments which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
HbA1c ≥ 12% and/or recent signs of uncontrolled diabetes
Any clinically significant disorder or condition or disease (e.g. cardiovascular, renal conditions) that would make the participant unsuitable for the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03397264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.