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

Completed · Phase 1

Conditions studied: Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00536016

Run by

Jerini Ophthalmic

People needed

36

Starts

2007-09-01

Expected to finish

2009-12-01

Last updated by the study team

2010-09-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Retina Vitreous Associates Medical Group — Beverly Hills, California, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• William Beaumont Research Institute — Royal Oak, Michigan, United States
• Dean McGee Eye Institute — Oklahoma City, Oklahoma, United States
• Palmetto Retina Center — West Columbia, South Carolina, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Vitreoretinal Consultants — Houston, Texas, United States
• Valley Retina Institute — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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