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

Sponsor
TargeGen (Industry)
Overall Status
Terminated
CT.gov ID
NCT00509548
Collaborator
(none)
7
Enrollment
8
Locations
2
Arms
8
Duration (Months)
0.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Jul 1, 2007
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Arms and Interventions

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

Primary Outcome Measures

  1. Change from baseline in central retinal/lesion thickness as measured by OCT at Week 4. [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. [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

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

Sponsors and Collaborators

  • TargeGen

Investigators

  • Principal Investigator: Peter Kaiser, M.D., The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00509548
Other Study ID Numbers:
  • OPH-TG100801-002
First Posted:
Jul 31, 2007
Last Update Posted:
Mar 29, 2010
Last Verified:
Mar 1, 2010
Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic

Study Results

No Results Posted as of Mar 29, 2010