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Stop Retinal Ganglion Cell Dysfunction Study (STOP-RGCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390284
Recruitment Status : Active, not recruiting
First Posted : March 17, 2015
Last Update Posted : October 19, 2022
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Vittorio Porciatti, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Latanoprost Drug: Bimatoprost Drug: Travoprost Drug: Timolol Drug: Dorzolamide Drug: Brinzolamide Drug: Acetazolamide Drug: Methazolamide Phase 3

Detailed Description:

The PERG is recorded from small metallic buttons taped on the skin similarly to an electrocardiogram, with the difference that the electrodes are around the eyes.

The only physical contact you will experience is a gentle cleaning of the skin with an alcohol prep pad. During the test you must look with both eyes at a Television (TV) display for about 3 minutes. During the follow up period you may be asked to take one more PERG test lying down in a bed.

This will cause a momentary increase of your eye pressure similar to the one that occurs during your normal sleep. This may help to understand whether or not your optic nerve functions normally when the pressure in your eye increases. For OCT evaluation, the pupil has to be dilated with drops as you did before for your eye exam. You have to briefly look at a mark inside the instrument one eye at a time.

PERG and OCT will be performed during the same day of your visit with the eye doctor. If you have already done these tests in the past, as part of another study or as part of your standard treatment, the results of these tests will be obtained from your record, and be included in this study.

If you are a participant in the Observation Group, you will be monitored with PERG, OCT, and standard clinical examinations every six months until close of study. If you are a participant in the Medication Group you will be also treated with eye drop medicines.

RISKS:

There are certain risks and discomforts that may be associated with this research. You should be aware that you are at risk of developing glaucoma whether you participate in the study or not. It is not known whether the risk of developing glaucoma is reduced by eye drops to lower eye pressure; the study will attempt to answer this question.

For the PERG, the only significant risk to you is a small chance of a rash to the cleansing agent for skin electrodes, which should go away without treatment. For OCT, there is a rare risk to you of an allergic reaction to the drops used to dilate your pupils. The risk is even lower if you did not have any reaction during your previous eye exams. In case of an allergic reaction, your eye doctor will immediately treat it. If you had previous problems with pupil dilation, you may wish to speak to your eye doctor about the option of doing this additional test.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stop Retinal Ganglion Cell Dysfunction Study
Actual Study Start Date : September 2015
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Abnormal PERG Untreated
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
Experimental: Abnormal PERG Treated

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
Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
Other Name: Xalatan

Drug: Bimatoprost
Lower intraocular pressure by increasing outflow of fluid from the eye.
Other Name: Lumigan

Drug: Travoprost
Lower intraocular pressure by increasing outflow of fluid from the eye.
Other Name: Travatan

Drug: Timolol
Lower intraocular pressure by decreasing production of fluid
Other Name: Timoptic

Drug: Dorzolamide
Lowers intraocular pressure by decreasing intraocular fluid production
Other Name: Trusopt

Drug: Brinzolamide
Lowers intraocular pressure by decreasing intraocular fluid production
Other Name: Azopt

Drug: Acetazolamide
Lowers intraocular pressure by decreasing intraocular fluid production
Other Name: Diamox

Drug: Methazolamide
Lowers intraocular pressure by decreasing intraocular fluid production
Other Name: Neptazane
No Intervention: Normal
Patients with a normal PERG test that will go through the study under observation.


Outcome Measures
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Primary Outcome Measures :
  1. Change in retinal nerve fiber layer thickness [ Time Frame: Baseline, 4 years ]
    As measured by Optical Coherence Tomography


Secondary Outcome Measures :
  1. Change in Pattern Electroretinogram Amplitude [ Time Frame: Baseline, 4 years ]
    Assessed via Pattern Electroretinogram in microvolts

  2. Change in Pattern Electroretinogram Phase [ Time Frame: Baseline, 4 years ]
    Assessed via Pattern Electroretinogram in degrees


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18 to 85 years, inclusive
  2. Refractive errors within -5 to +3 diopters
  3. Best corrected visual acuity (BCVA) better than or equal to 20/30 (Snellen)
  4. 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)
  5. Minimum untreated Intraocular pressure IOP of 15 mm Hg

  6. 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

Exclusion Criteria:

  1. Age-related macular degeneration
  2. Diabetes
  3. Parkinson's disease
  4. Multiple sclerosis
  5. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
  6. Pregnant or nursing women.
  7. Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.
  8. 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.
  9. An OCT abnormal enough in a pattern consistent with glaucoma.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02390284


Locations
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United States, Florida
Bascom Palmer Eye Institute - University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Eye Institute (NEI)
Investigators
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Principal Investigator: Vittorio Porciattti, DSc University of Miami
More Information
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Responsible Party: Vittorio Porciatti, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02390284    
Other Study ID Numbers: 20140587
R01EY014957 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Vittorio Porciatti, University of Miami:
RGCD
Glaucoma Suspect
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Bimatoprost
Travoprost
Dorzolamide
Acetazolamide
Methazolamide
Latanoprost
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Diuretics
Natriuretic Agents