Intravitreal Aflibercept Injection for Radiation Retinopathy

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT01579760
Phase
PHASE1
Status
Completed

Conditions

  • Macular Edema
  • Radiation Retinopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept every 2 months — DRUG
    2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10)
  • Aflibercept monthly — DRUG
    2.0mg aflibercept intravitreal injections every month (M0-11)

Study Details

The purpose of this study is to assess the safety of intravitreal aflibercept injection - in the treatment of macular edema associated with retinopathy secondary to previous radiation therapy.

Key Dates

Start date
Nov 30, 2012
Status verified
Apr 2019
Primary completion
Jan 31, 2019
Completion
Mar 27, 2019

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: aflibercept every 2 months
  • Experimental: aflibercept monthly

Primary Outcome Measure

Incidence of adverse events [ Time Frame: 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-
Retina Consultants of HoustonHoustonTexas77030-

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Washington University School of Medicine· St Louis, MORetina Consultants of Houston· Houston, TX

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