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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 1 Safety Study of TG100801 Eye Drops in Healthy Volunteers

NCT00414999

Macular Degeneration Diabetic Retinopathy

COMPLETED PHASE1

Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD

NCT02859766

Macular Degeneration

COMPLETED PHASE1

A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration

NCT00090532

Age-Related Macular Degeneration

TERMINATED PHASE1/PHASE2

A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration

NCT01749891

Macular Degeneration

COMPLETED PHASE1/PHASE2

Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)

NCT01024998

Macular Degeneration Age-Related Maculopathies Age-Related Maculopathy +7 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Degeneration Choroidal Neovascularization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Dose 1

Group Type EXPERIMENTAL

TG100801

Intervention Type DRUG

Eye drop, twice a day, 30 days.

2

Dose 2

Group Type EXPERIMENTAL

TG100801

Intervention Type DRUG

Eye drop, twice a day, 30 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TG100801

Eye drop, twice a day, 30 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No