Open-Label, Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD
Information source: TargeGen
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Degeneration; Choroidal Neovascularization
Intervention: TG100801 (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: TargeGen
Official(s) and/or principal investigator(s):
Peter Kaiser, M.D., Principal Investigator, Affiliation: Cleveland Clinic
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
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 design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline in central retinal/lesion thickness as measured by OCT at Week 4.
Secondary outcome: 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.
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.
Minimum age: 50 Years.
Maximum age: N/A.
- 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
- 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
- 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
- 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
Locations and Contacts
Retina Centers, PC, Tucson, Arizona 85704, United States
Retina-Vitreous Associates Medical Group, Beverly Hills, California 90211, United States
Center for Retina and Macular Disease, Winter Haven, Florida 33880, United States
Ophthalmic Consultants of Boston, Boston, Massachusetts 02114, United States
Vitreous-Retina-Macula Consultants of New York, New York, New York 10022, United States
Cleveland Clinic, Cleveland, Ohio 44195, United States
Black Hills Regional Eye Institute, Rapid City, South Dakota 57701, United States
Vitreoretinal Consultants, Houston, Texas 77030, United States
American Macular Degeneration Foundation
Starting date: July 2007
Last updated: January 8, 2008