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DRCR W

TRIAL DESCRIPTION SUMMARY:


Patients diagnosed with diabetes may be eligible for this research clinical trial studying treatment for possible prevention of vision threatening diabetic retinopathy.  So the objective of this trial is to learn if Aflibercept if effective in preventing ocular complications from diabetes, and compare long-term visual outcomes in eyes that receive Aflibercept early vs. those that are initially observed.

Participants are randomly assigned to Aflibercept or Observation (a sham or fake injection) given every 4 months after three initial loading doses one month apart in the beginning.  Visits are every 4 months.  If diabetic retinopathy develops, treatment will be given.


BASIC TRIAL INFORMATION:


Phase:       IV
Disease:    Diabetic Retinopathy
Age:          18 Years or Older
Sponsor:   Diabetic Retinopathy Clinical Research Network (DRCR.net)
Status:      Currently Enrolling
Length:     4 Years


ELEGIBILITY CRITERIA:


Key Inclusion Criteria:

  1. 18 years of age or older.
  2. Type 1 or type 2 diabetes.
  3. Diagnosed with Severe Nonproliferative Diabetic Retinopathy.
  4. No Diabetic Macular Edema.
  5. Visual Acuity (BCVA) of 20/25 or better.

Key Exclusion Criteria:

  1. Any history of prior pan-retinal photocoagulation (PRP).
  2. Past treatment with laser or intraocular injections within the last 12 months.
  3. Using no more than one topical glaucoma medication.

TRIAL CONTACT INFORMATION:


Sites:  Beachwood, Middleburg Heights, and Youngstown
Study Coordinator:  Janine Davis
Email: jdavis@retina-assoc.com
Phone: 216-831-5700