Stop Retinal Ganglion Cell Dysfunction Study

NCT02390284 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: 20140587R01EY014957
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

RGCD; Glaucoma Suspect

Outcome Measures

Primary Outcomes (1)

• Retinal Nerve Fiber Layer Thickness

  As measured by Optical Coherence Tomography in different timepoints as an absolute value in micrometers.

  Baseline

Secondary Outcomes (2)

• Pattern Electroretinogram Amplitude

  Baseline

• Pattern Electroretinogram Phase

  Baseline

Study Arms (3)

Abnormal PERG Untreated

NO INTERVENTION

Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.

Abnormal PERG Treated

EXPERIMENTAL

Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to receive one or more drops in each eye in order to reduce the intraocular pressure by 20%. Drugs could be: Latanoprost 1 drop Once a day (QD) Bimatoprost 1 drop QD Travoprost 1 drop QD Timolol 1 drop Twice a day (BID) Dorzolamide 1 drop Three times a day (TID) Brinzolamide 1 drop BID Acetazolamide and Methazolamide depends on clinicians evaluation. If Clinicians consider necessary, he/she might combine 2 drugs in order to get the desired intraocular pressure.

Drug: Latanoprost; Drug: Bimatoprost; Drug: Travoprost; Drug: Timolol; Drug: Dorzolamide; Drug: Brinzolamide; Drug: Acetazolamide; Drug: Methazolamide

Normal

NO INTERVENTION

Patients with a normal PERG test that will go through the study under observation.

Interventions

Latanoprost DRUG

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

Also known as: Xalatan

Abnormal PERG Treated

Bimatoprost DRUG

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

Also known as: Lumigan

Abnormal PERG Treated

Travoprost DRUG

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

Also known as: Travatan

Abnormal PERG Treated

Timolol DRUG

Lower intraocular pressure by decreasing production of fluid

Also known as: Timoptic

Abnormal PERG Treated

Dorzolamide DRUG

Lowers intraocular pressure by decreasing intraocular fluid production

Also known as: Trusopt

Abnormal PERG Treated

Brinzolamide DRUG

Lowers intraocular pressure by decreasing intraocular fluid production

Also known as: Azopt

Abnormal PERG Treated

Acetazolamide DRUG

Lowers intraocular pressure by decreasing intraocular fluid production

Also known as: Diamox

Abnormal PERG Treated

Methazolamide DRUG

Lowers intraocular pressure by decreasing intraocular fluid production

Also known as: Neptazane

Abnormal PERG Treated

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85 years, inclusive
• Refractive errors within -5 to +3 diopters
• Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
• Normal standard automated perimetry (SAP) according to the Ocular Hypertension Treatment Study (OHTS) criteria15 (reliability \< 15% on all indices, normality \> 5% on all global indices in two consecutive sessions 6 months apart)
• Minimum untreated Intraocular pressure IOP of 15 mm Hg
• Glaucoma Suspect Status defined as one or more of the following:
• Glaucomatous optic disc appearance (vertical cup-to-disc ratio \[C/D\] ≥0.5
• Cup disc ratio asymmetry ≥0.2
• Localized thinning of the disc
• Presence or history of splinter disc hemorrhage
• Moderately increased IOP (\>21 to \<28 mm Hg).
• Family history of vision loss for glaucoma

You may not qualify if:

• Age-related macular degeneration
• Diabetes
• Parkinson's disease
• Multiple sclerosis
• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
• Pregnant or nursing women.
• Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
• An OHTS risk score high enough in the judgment of the ophthalmologist or optometrist managing the patient to recommend pressure lowering medicine to the patient and not randomization.
• An OCT abnormal enough in a pattern consistent with glaucoma.

Sponsors & Collaborators

• University of Miami: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Bascom Palmer Eye Institute - University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Interventions

Latanoprost; Bimatoprost; Travoprost; Timolol; dorzolamide; brinzolamide; Acetazolamide; Methazolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Organic Chemicals; Cloprostenol; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed and qualifying for the study.

Results Point of Contact

• Title: Dr. Vittorio Porciatti
• Organization: University of Miami

vporciatti@med.miami.edu

3053266050

Study Officials

• Vittorio Porciattti, DSc

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: September 1, 2015
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)