- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00509548
Open-Label, Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85704
- Retina Centers, PC
-
-
California
-
Beverly Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group
-
-
Florida
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Winter Haven, Florida, United States, 33880
- Center for Retina and Macular Disease
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Ophthalmic Consultants of Boston
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New York
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New York, New York, United States, 10022
- Vitreous-Retina-Macula Consultants of New York
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-
Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Black Hills Regional Eye Institute
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Texas
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Houston, Texas, United States, 77030
- Vitreoretinal Consultants
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Dose 1
|
Eye drop, twice a day, 30 days.
|
EXPERIMENTAL: 2
Dose 2
|
Eye drop, twice a day, 30 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in central retinal/lesion thickness as measured by OCT at Week 4.
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Kaiser, M.D., The Cleveland Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPH-TG100801-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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