Open-Label, Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Wet age-related macular degeneration (AMD) is caused by the formation and growth of abnormal blood vessels (angiogenesis) in the retina. The new blood vessels have fragile walls and can leak fluid into the retina. The build-up of fluid (edema) under the macula can distort vision or cause vision loss. TG100801 is a topical (eye drop) therapy that has been shown to inhibit ocular angiogenesis, vascular leak, and inflammation in laboratory studies. The primary purpose of this pilot study is to evaluate the ability of topical administration of TG100801 to reduce the amount of fluid in the retina in patients with AMD following 30 days of treatment. An additional objective is to evaluate the safety of TG100801 in patients with AMD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TargeGen

Criteria

Inclusion Criteria:

• Subfoveal CNV secondary to AMD in study eye

• CNV lesion size less than or equal to 12 MPS disk areas

• CNV > 50% of lesion area

• Presence of intraretinal fluid causing an increase in central subfield thickness of at least 250 microns, confirmed by OCT in study eye

• Any lesion composition

• Best corrected visual acuity of 20/40 to 20/320 (73 to 24 ETDRS letters) at 4 meters in study eye

• Best corrected visual acuity of 20/800 or better (at least 4 ETDRS letters) at 4 meters in fellow eye

• Ability to administer and tolerate eye drops

• Able to give written informed consent

Exclusion Criteria:

• History of any treatment for subfoveal CNV in study eye

• Known or anticipated need for use of topical medication in study eye during 30-day dosing period

• Current or anticipated need for any available ocular anti-VEGF therapy in fellow eye for 30 days prior to and 30 days following baseline

• RPE rip or tear in study eye

• Blood > 1 disk area, atrophy, or fibrosis (disciform scar) under foveal center of study eye

• Scarring/fibrosis of at least 25% of total CNV lesion in study eye

• Hemorrhage or PED > 50% of total CNV lesion in study eye

• Glaucoma with visual field loss or IOP at least 25 mmHg in study eye or consistently at least 25 mmHg in fellow eye