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

Macular Degeneration Clinical Trial

Official title:

An Open-Label Randomized Pilot Study of Safety and Preliminary Efficacy of TG100801 in Patients With Choroidal Neovascularization Due to Age-Related Macular Degeneration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00509548
• Other study ID #: OPH-TG100801-002
• Status: Terminated
• Phase: Phase 2
• First received: July 27, 2007
• Last updated: March 25, 2010
• Start date: July 2007
• Est. completion date: March 2008

Study information

• Verified date: March 2010
• Source: TargeGen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• TG100801
Eye drop, twice a day, 30 days.

Locations

Country	Name	City	State
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Vitreoretinal Consultants	Houston	Texas
United States	Vitreous-Retina-Macula Consultants of New York	New York	New York
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Retina Centers, PC	Tucson	Arizona
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
TargeGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in central retinal/lesion thickness as measured by OCT at Week 4.		4 weeks	No
Secondary	Mean/median change in visual acuity from baseline. Proportion of subjects with loss of > 15 ETDRS letters. Proportion of subjects with loss of > 30 ETDRS letters. Proportion of subjects gaining at least 15 letters.		4 weeks	No

External Links

•   American Macular Degeneration Foundation