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

TargeGen

Status and phase

Terminated

Phase 2

Conditions

Choroidal Neovascularization

Macular Degeneration

Treatments

Drug: TG100801

Study type

Interventional

Funder types

Industry

Identifiers

NCT00509548

OPH-TG100801-002

Details and patient eligibility

About

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.

Full description

Choroidal neovascularization (CNV) due to AMD is the leading cause of irreversible, severe vision loss in people 55 years and older in the developed world. TG100801 is a potent inhibitor of vascular growth endothelial factor (VEGF) and other kinases that contribute to CNV and macular edema. Animal models have demonstrated the ability of TG100801 to inhibit angiogenesis, vascular leak, and inflammation. TG100801 is being developed as a topical (eye drop) therapy for treatment of CNV due to AMD.

The primary objective of this multicenter, open-label, randomized, pilot study is to evaluate the effects of 30 days of dosing with two dose levels of TG100801 on central retinal/lesion thickness, as measured by optical coherence tomography (OCT). The safety of TG100801 in patients with AMD also will be evaluated.

Enrollment

7 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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