Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Retina Research Institute, LLC
Study ID
NCT01657669
Phase
PHASE4
Status
Unknown

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Intravitreal Aflibercept injection — DRUG
    Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.

Study Details

This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).

Key Dates

Start date
Oct 31, 2012
Status verified
Oct 2017
Primary completion
Nov 30, 2014
Completion
Dec 31, 2017

Study Design

Enrollment
22 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Intravitreal Aflibercept injection
    Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mg) via intravitreal injection once every 8 weeks (2 months).

Primary Outcome Measure

Resolution time of intraretinal cysts and sub retinal fluid on OCT [ Time Frame: 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
The Retina InstituteSt LouisMissouri63128-
The Retina InstituteSt LouisMissouri63141-
Valley Retina InstituteMcAllenTexas78503-

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