NCT00509548

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 29, 2010

Status Verified

March 1, 2010

Enrollment Period

8 months

First QC Date

July 27, 2007

Last Update Submit

March 25, 2010

Conditions

Macular DegenerationChoroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (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

Study Arms (2)

1

EXPERIMENTAL

Dose 1

Drug: TG100801

2

EXPERIMENTAL

Dose 2

Drug: TG100801

Interventions

TG100801DRUG

Eye drop, twice a day, 30 days.

12

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Retina Centers, PC

Tucson, Arizona, 85704, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Vitreous-Retina-Macula Consultants of New York

New York, New York, 10022, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Vitreoretinal Consultants

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Interventions

4-chloro-3-(5-methyl-3-((4-(2-pyrrolidin-1-ylethoxy)phenyl)amino)-1,2,4-benzotriazin-7-yl)phenol

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Kaiser, M.D.

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 27, 2007

First Posted

July 31, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 29, 2010

Record last verified: 2010-03

Locations

US(8)