Trial intelligence / Profile preview

ORION-1: AR-1105 in RVO

NCT03739593Phase 2

Key facts

Status: Completed
Start: Mar 2019
Primary completion: May 2020
Countries: 1
Sponsor: Aerie Pharmaceuticals
Modality: Biodegradable Polymers, Small Molecules

Drugs: AR-1105
Conditions: macular edema

Overview

Phase 2, randomised, open-label trial of AR-1105 in macular edema (2 arms), sponsored by Aerie Pharmaceuticals. Primary endpoint: Number of Ocular and Non-ocular TEAEs at 6 months. Started Mar 2019; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

AR-1105-CF1
Single dose of AR-1105-CF1 (340 mcg dexamethasone)
AR-1105-CF2
Single dose of AR-1105-CF2 (340 mcg dexamethasone)

Who it enrols

Adults with macular edema due to CRVO or BRVO, with specific visual acuity and retinal thickness criteria, excluding those with glaucoma, ocular hypertension, or recent prior ocular treatments.

Endpoints

Primary

Number of Ocular and Non-ocular TEAEs6 months

Secondary

Best-Corrected Visual Acuity6 months
Central Retinal Thickness6 months

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