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

Primary Purpose

Macular Degeneration, Choroidal Neovascularization

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TG100801
Sponsored by
TargeGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina Centers, PC
  • Retina-Vitreous Associates Medical Group
  • Center for Retina and Macular Disease
  • Ophthalmic Consultants of Boston
  • Vitreous-Retina-Macula Consultants of New York
  • Cleveland Clinic
  • Black Hills Regional Eye Institute
  • Vitreoretinal Consultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Dose 1

Dose 2

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
July 27, 2007
Last Updated
March 25, 2010
Sponsor
TargeGen
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1. Study Identification

Unique Protocol Identification Number
NCT00509548
Brief Title
Open-Label, Pilot Study of TG100801 in Patients With Choroidal Neovascularization Due to AMD
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 Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
TargeGen

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Choroidal Neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Dose 1
Arm Title
2
Arm Type
Experimental
Arm Description
Dose 2
Intervention Type
Drug
Intervention Name(s)
TG100801
Intervention Description
Eye drop, twice a day, 30 days.
Primary Outcome Measure Information:
Title
Change from baseline in central retinal/lesion thickness as measured by OCT at Week 4.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Kaiser, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Centers, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Vitreous-Retina-Macula Consultants of New York
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Vitreoretinal Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.macular.org
Description
American Macular Degeneration Foundation

Learn more about this trial

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

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