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

This study has been terminated.
Sponsor:
Information provided by:
TargeGen
ClinicalTrials.gov Identifier:
NCT00509548
First received: July 27, 2007
Last updated: March 25, 2010
Last verified: March 2010
History of Changes
  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 2

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 7
Study Start Date: July 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose 1
 Drug: TG100801
Eye drop, twice a day, 30 days.
Experimental: 2
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. The Cleveland Clinic
  More Information

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

No publications provided

Responsible Party: Jolene Shorr/Senior Director, Clinical Development, TargeGen, Inc.
ClinicalTrials.gov Identifier: NCT00509548     History of Changes
Other Study ID Numbers: OPH-TG100801-002
Study First Received: July 27, 2007
Last Updated: March 25, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on October 17, 2012