A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye. Repeated dosages will also be given to determine the highest safe dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jerini Ophthalmic

Criteria

Inclusion Criteria:

• Best corrected visual acuity in the study eye between 5 and 7 letters inclusive using and ETDRS chart (Snellen equivalent of appx. 20/800 to 20/40.

• Subfoveal choroidal neovascularization (CNV) due to AMD.

• Total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≤ 12 DA, of which at least 25% must be active CNV.

• For patients with occult or non classic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of three or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks.

• Clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening.

• Intraocular pressure of 21 mm Hg or less.

• Retinal thickness ≥ 250 μm by OCT.

• Normal screening ERG

• Normal ECG

Exclusion Criteria:

• PDT within 120 days prior to screening in the study eye.

• Previous therapeutic radiation to the eye.

• Any retinovascular disease or retinal degeneration other than AMD.

• Serous pigment epithelial detachment without the presence of neovascularization.

• Presence of pigment epithelial tears or rips.

• Previous posterior vitrectomy or retinal surgery.

• Any periocular infection in the past 4 weeks.

• Concomitant therapy with anti-VEGF therapies, e.g. Avastin, Lucentis or Macugen, or previous use of these agents within 60 days of screening in the study eye.

• Concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening.

• Cataract surgery in the study eye within three months of screening.

• Intraocular surgery in the study eye within three months of screening.

• Presence of ocular infection in the study eye.

• Presence of severe myopia (-8 diopters or greater) in the study eye.

• Allergy to or prior significant adverse reaction to fluorescein.

• Any major surgical procedure within one month of trial entry.