At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 49 enrolled
Drug / intervention
AR-1105-CF1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Safety and Proof-of-concept Study to Assess Safety, Tolerability and Efficacy of AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
In Brief
A Phase 2 clinical trial evaluating AR-1105-CF1 and AR-1105-CF2 for Macular Edema. Completed, enrolled 49 participants across 11 sites.
Detailed Summary
This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO). A more durable intravitreal implant containing a low dose of dexamethasone may result in less frequent retreatments, and potentially lower the incidence of steroid-related side effects without compromising efficacy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartMar 2019
Primary CompletionMay 2020
Study CompletionJul 2020
TodayJul 2026
First PostedNov 14, 2018
Enrollment StartMar 13, 2019
Primary CompletionMay 14, 2020
Study CompletionJul 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.6 years ago
Interventions
AR-1105-CF1drug
AR-1105 clinical formulation 1 (AR-1105-CF1)
AR-1105-CF2drug
AR-1105 clinical formulation 2 (AR-1105-CF2)