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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00509548
Recruitment Status : Terminated
First Posted : July 31, 2007
Last Update Posted : March 29, 2010
Sponsor:
Information provided by:
TargeGen

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Choroidal Neovascularization Drug: TG100801 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in central retinal/lesion thickness as measured by OCT at Week 4. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509548


Locations
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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
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Principal Investigator: Peter Kaiser, M.D. The Cleveland Clinic
More Information
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Additional Information:

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Responsible Party: Jolene Shorr/Senior Director, Clinical Development, TargeGen, Inc.
ClinicalTrials.gov Identifier: NCT00509548    
Other Study ID Numbers: OPH-TG100801-002
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases