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

Sponsored by:	TargeGen
Information provided by:	TargeGen
ClinicalTrials.gov Identifier:	NCT00509548

Purpose

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.

Condition	Intervention	Phase
Macular Degeneration Choroidal Neovascularization	Drug: TG100801	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by TargeGen:

Primary Outcome Measures:

Change from baseline in central retinal/lesion thickness as measured by OCT at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2007

Arms	Assigned Interventions
1: Experimental Dose 1	Drug: TG100801 Eye drop, twice a day, 30 days.
2: Experimental Dose 2	Drug: TG100801 Eye drop, twice a day, 30 days.

Detailed 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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509548

Locations

United States, Arizona
Retina Centers, PC
Tucson, Arizona, United States, 85704
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Florida
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
United States, New York
Vitreous-Retina-Macula Consultants of New York
New York, New York, United States, 10022
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
Vitreoretinal Consultants
Houston, Texas, United States, 77030

Sponsors and Collaborators

TargeGen

Investigators

Principal Investigator:

Peter Kaiser, M.D.

Cleveland Clinic

More Information

American Macular Degeneration Foundation This link exits the ClinicalTrials.gov site

Responsible Party:	TargeGen, Inc. ( Jolene Shorr/Senior Director, Clinical Development )
Study ID Numbers:	OPH-TG100801-002
Study First Received:	July 27, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00509548
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Retinal Degeneration
Macular Degeneration

Tetrahydrozoline
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009