Study Detail: Sirion Geographic Atrophy

Phase II Randomized Double-Masked, Placebo-Controlled, Dose-Comparison Study of the Safety and Efficacy of Fenretinide in the tx of GA in AMD. Pts. randomized in 1:1:1 ratio of 300mg, 100mg or Placebo.

Trial Description

Summary

Study of the safety and effectiveness of an experimental oral drug (Fenretinide) taken every day. The patient will be randomized (chosen like the flip of a coin) to one of three doses- 300mg, 100mg, or placebo. The patient and the MD are not informed which does is being taken. The patient must take 3 capsules every day after their evening meal. Ocuvite PreserVision Vitamins with Lutein and without beta carotene are provided to the patient for free for the life of the study.

Basic Trial Information

Study Duration

9 visits over 2 years- 5 visits in the first 6 months followed by 4 visits over the next 18 months.

Eligibility Criteria

Inclusion Criteria

• GA-one or more discrete areas of loss of RPE with total atrophic area of 2.55 mm2 - 20.32 mm2 measured by FA (measure all and do a sum total). Approximately >1 to 8 disc areas.
• GA must show an autofluorescence pattern other than those graded as "none", "focal" or "patchy". Banded and diffuse patterns are accepted.
• GA must be within 250 ¼ m of fovea
• Va 20/20- 20/100 (best corrected). No FE Va restrictions.
• Please check with the clinical coordinator for other inclusion criteria

Exclusion Criteria

• GA due to any other disease other than AMD (eg, drug-induced)
• No pattern dystrophy of the RPE and no fibrosis in the SE
• Ocular surgery in the SE in the previous 3 months.
• Current or hx of CNV in the study eye
• Active CNV in the fellow eye
• Prior systemic or intraocular use in either eye of anti-VEGF drugs in the previous 3 months
• Prior laser photocoagulation or PDT in the study eye
• Any intravitreal injection of any drug in either eye in the previous 3 months
• Glaucomatous VF or disc cupping in the SE
• Diabetic retinopathy or other retinal vascular disease in either eye
• Moderate or severe dry eye
• Myopia greater than 8D or Hyperopia greater than 8D in the SE
• Inflammatory disease of retina, uvea or choroid in either eye within one year
• Current use of Retin-A or Accutane
• Systemic steroid use within 1 month
• Unwillingness to discontinue Vitamin A or Beta-carotene supplements
• Unwillingness to discontinue zeaxanthine or lutein supplements or to modify extreme diets
• Vitamin A deficiency
• Malignancies or other life-threatening diseases
• Hx of CVA, coronary events or heart failure with 1 year
• Hx of abnormal cardiac rhythm not controlled on meds
• Renal insufficiency or poor liver functioning (determined by lab tests at screening)
• Please check with the clinical coordinator for other exclusion criteria

Trial Contact Information