Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

Conditions

• Macular Edema
• Retinal Vein Occlusion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• suprachoroidal CLS-TA — DRUG
  suprachoroidal injection of CLS-TA
• suprachoroidal sham — DRUG
  suprachoroidal sham procedure
• IVT aflibercept — DRUG
  2 mg intravitreal injection of aflibercept

Study Details

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

Key Dates

Start date

Jan 31, 2017

Status verified

Mar 2021

Primary completion

Dec 10, 2018

Completion

Dec 10, 2018

Study Design

Enrollment

460 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Active
  IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 µL) SC injections
• Active Comparator: Control
  IVT aflibercept (2 mg/0.05 mL) + sham SC procedure

Primary Outcome Measure

Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) [ Time Frame: 2 months ]

Locations (58)

Find similar trials in Peoria, AZ

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