Geographic atrophy treatment evaluation (GATE)

• Research type

  Research Study

• Full title

  The safety and efficacy of AL-8309B Ophthalmic solution for the treatment of GEOGRAPHIC ATROPHY(GA) SECONDARY TO AGE-RELATED MACULAR DEGENERATION (AMD)

• IRAS ID

  21972

• Eudract number

  2008-007705-37

• Research summary

  The advanced form of age-related macular degeneration (AMD) has two phenotypes which result in sight loss (a) neovascular and (b) atrophic. The latter is termed Geographic Atrophy (GA) for which there is no treatment. GA consists of a lesion or well demarcated area with an apparent lack of retinal pigment epithelium (RPE) and photoreceptors. The lesion can be measured using a technique called Fundus Auflurescence (FAF). The aim of the GATE study is to examine the efficacy of a compound AL8309B, which is administered as eye drops, in slowing the expansion and progression of the atrophic areas or lesions.To be eligible for the study, patients must have GA due to AMD. Patients are evaluated approximately 16 times over 3 years. Their exams include complete eye examinations as well as physical exams and blood analysis. The growth of the lesion will be measured over the course of the study using FAF collected every 6 months.

• REC name

  HSC REC B

• REC reference

  09/NIR02/45

• Date of REC Opinion

  29 Sep 2009

• REC opinion

  Further Information Favourable Opinion