Stop Retinal Ganglion Cell Dysfunction Study

Summary

Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease, predicting its severity and the benefit of pressure lowering eye drops is key to clinical management aimed at maintaining useful vision with advancing age. This study will longitudinally monitor a population of glaucoma suspects (with positive factors for the disease but with normal vision) with noninvasive pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) that are the parent neurons of the optic nerve. RGCs may become dysfunctional before dying and their function restored with pressure-lowering eye drops. Glaucoma suspects with abnormal PERG will be randomized to treatment with eye drops, while those with normal PERG will be left untreated. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests every 6 months over 4 years.

Conditions

• Glaucoma

Interventions

DRUG

Latanoprost

Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.

DRUG

Bimatoprost

Lower intraocular pressure by increasing outflow of fluid from the eye.

DRUG

Travoprost

Lower intraocular pressure by increasing outflow of fluid from the eye.

DRUG

Timolol

Lower intraocular pressure by decreasing production of fluid

DRUG

Dorzolamide

Lowers intraocular pressure by decreasing intraocular fluid production

DRUG

Brinzolamide

Lowers intraocular pressure by decreasing intraocular fluid production

DRUG

Acetazolamide

Lowers intraocular pressure by decreasing intraocular fluid production

DRUG

Methazolamide

Lowers intraocular pressure by decreasing intraocular fluid production

Sponsors & Collaborators

• National Eye Institute (NEI)

  collaborator NIH

• University of Miami

  lead OTHER

Principal Investigators

• Vittorio Porciattti, DSc · University of Miami

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2024-10-04

Completion

2024-10-04

FDA Drug

Yes

Countries

• United States

Study Locations