Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

Sirion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Geographic Atrophy; Dry Age Related Macular Degeneration

Treatments: Drug: Fenretinide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00429936

SRFR-001

Details and patient eligibility

About

The purpose of this phase II study is to determine the efficacy of fenretinide in the treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular degeneration (AMD).

Enrollment: 245 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• males or females, 50 to 89 years of age
• must have GA from AMD in one or both eyes

Exclusion criteria

• GA due to any disease other than AMD (eg, drug-induced)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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245 participants in 3 patient groups, including a placebo group

100 mg fenretinide softgel capsules

Active Comparator group

Description:

Three (3) 100-mg fenretinide softgel capsules

Treatment:

Drug: Fenretinide

Fenretinide and placebo softgel capsules

Active Comparator group

Description:

One (1) 100-mg fenretinide softgel capsule and two (2) placebo softgel capsules

Treatment:

Drug: Fenretinide

Placebo softgel capsules

Placebo Comparator group

Description:

Three (3) placebo softgel capsules

Treatment:

Drug: Fenretinide