Retina Associates - Research Coordinators
 
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Study Detail: Alcon GAP

Trial Description Summary : This is a natural history study being done to assess the rate of progression of geographic atrophy by measuring the growth of the atrophic lesions.

 

Basic Trial Information

Phase

Disease

Status

Age

Sponsor

Protocol #

NA

Geographic Atrophy

Enrolling

55+

Alcon

C-06-30

Study Duration: 18 months

 

Eligibility Criteria:

      Inclusion Criteria

  • Primary study eye must have a contiguous well-demarcated area of GA larger than 2.5 mm² and less than or equal to 12 mm² (>1 to ≤ 5 DA).
  • Best corrected vision in study eye is 20/100 or better.
  • Non-study eye must have either drusen ≥ 63 µm or Geographic Atrophy
  • Other inclusion criteria per the study coordinator

       

      Exclusion Criteria

  • Presence or history of CNV in either eye.
  • Any ocular surgery within 90 days prior to the Baseline Visit.
  • Current participation in other studies and previous or concomitant therapy to treat AMD.
  • Other exclusion criteria per the study coordinator

      General Medical Exclusion Criteria

  • Any systemic disease with a limited survival prognosis (e.g., cancer, severe/unstable cardiovascular disease).
  • Known medical history of allergy or sensitivity to fluorescein dye that is clinically relevant.
  • Evidence of significant uncontrolled concomitant diseases such as cardiovascular, neurological, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
  • Other general inclusion/exclusion criteria per the study coordinator

       

Study Title : The Natural History of Geographic Atrophy Progression (GAP) Secondary to Age-Related Macular Degeneration (AMD)

 

Trial Contact Information

Site

Study Coordinator

Beachwood

Vivian 216/831-5704 ext. 6800