CANadian Study in Patients With Wet AMD, Evaluating the Efficacy and Safety of Switching From Intravitreal Aflibercept to RanIbizumab

Conditions

• Wet Age-related Macular Degeneration (Wet AMD)

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  0.5 mg, intravitreal injection

Study Details

There are limited prospective data regarding the potential benefit and risks associated with switching between anti-VEGF therapies in patients with nAMD who have initially achieved a favorable response to the first anti-VEGF therapy used but subsequently have evidence of increasing disease activity despite continuation of therapy. This study will fill this knowledge gap by prospectively evaluating the effectiveness and safety of switching from aflibercept to ranibizumab in nAMD patients that have non - sustained response to initial treatment with aflibercept.

Key Dates

First listed

Dec 18, 2015

Start date

Mar 31, 2016

Status verified

Feb 2017

Primary completion

Dec 31, 2017

Completion

Dec 31, 2017

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Ranibizumab at 0.5 mg
  Single arm, intravitreal injection

Primary Outcome Measure

Mean change in Central Subfield Retinal Thickness (CSRT) [ Time Frame: at Day 90 (Month 3) and Day 180 (Month 6) ]