GlaucomaPhase 3STOP-RGCDNCT02390284
Stop Retinal Ganglion Cell Dysfunction Study
A Phase 3 study testing Latanoprost, Bimatoprost and Travoprost in people with Glaucoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Latanoprost, Bimatoprost and Travoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 4 Oct 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Currently using prescribed pressure lowering medicines and unwilling to be withdrawn from them.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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bascom Palmer Eye Institute - University of Miami
Miami, Florida, 33136
About this study
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Latanoprost, Bimatoprost, Travoprost, Timolol, Dorzolamide
- Keywords
- RGCD, Glaucoma Suspect
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
Also called Xalatan
Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
BimatoprostDrug
Also called Lumigan
Lower intraocular pressure by increasing outflow of fluid from the eye.
TravoprostDrug
Also called Travatan
Lower intraocular pressure by increasing outflow of fluid from the eye.
TimololDrug
Also called Timoptic
Lower intraocular pressure by decreasing production of fluid
DorzolamideDrug
Also called Trusopt
Lowers intraocular pressure by decreasing intraocular fluid production
BrinzolamideDrug
Also called Azopt
Lowers intraocular pressure by decreasing intraocular fluid production
AcetazolamideDrug
Also called Diamox
Lowers intraocular pressure by decreasing intraocular fluid production
MethazolamideDrug
Also called Neptazane
Lowers intraocular pressure by decreasing intraocular fluid production
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Nerve Fiber Layer Thickness
As measured by Optical Coherence Tomography in different timepoints as an absolute value in micrometers.
Measured: Baseline
Secondary outcomes (2)
Pattern Electroretinogram Amplitude
Assessed via Pattern Electroretinogram in nanovolts
Measured: Baseline
Pattern Electroretinogram Phase
Assessed via Pattern Electroretinogram in degrees
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startSep 2015
- Primary completion4 Oct 2024
- Study completion4 Oct 2024
Why it stopped: No patients had abnormal PERG and could not be included in the first two arms from the baseline timepoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Vittorio Porciatti, University of Miami
- Investigators
- Vittorio Porciattti, DSc, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390284
- Sponsor's protocol ID
- 20140587
- Other IDs
- R01EY014957
- Acronym
- STOP-RGCD
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2015
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Retinal Ganglion Cell Dysfunction Study
- ClinicalTrials.gov ID
- NCT02390284
- Acronym / sponsor ID
- STOP-RGCD / 20140587
- Conditions
- Glaucoma
- Keywords
- RGCD, Glaucoma Suspect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No patients had abnormal PERG and could not be included in the first two arms from the baseline timepoint.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Sep 2015 (actual)
- Primary completion
- 4 Oct 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Latanoprost, Drug: Bimatoprost, Drug: Travoprost, Drug: Timolol, Drug: Dorzolamide, Drug: Brinzolamide, Drug: Acetazolamide, Drug: MethazolamideParticipants 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. |
| Normal | No intervention | –Patients with a normal PERG test that will go through the study under observation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LatanoprostAlso: XalatanLower intraocular pressure (IOP) by increasing outflow of fluid from the eye. | Drug | Abnormal PERG Treated |
| BimatoprostAlso: LumiganLower intraocular pressure by increasing outflow of fluid from the eye. | Drug | Abnormal PERG Treated |
| TravoprostAlso: TravatanLower intraocular pressure by increasing outflow of fluid from the eye. | Drug | Abnormal PERG Treated |
| TimololAlso: TimopticLower intraocular pressure by decreasing production of fluid | Drug | Abnormal PERG Treated |
| DorzolamideAlso: TrusoptLowers intraocular pressure by decreasing intraocular fluid production | Drug | Abnormal PERG Treated |
| BrinzolamideAlso: AzoptLowers intraocular pressure by decreasing intraocular fluid production | Drug | Abnormal PERG Treated |
| AcetazolamideAlso: DiamoxLowers intraocular pressure by decreasing intraocular fluid production | Drug | Abnormal PERG Treated |
| MethazolamideAlso: NeptazaneLowers intraocular pressure by decreasing intraocular fluid production | Drug | Abnormal PERG Treated |
Primary outcome
Retinal Nerve Fiber Layer Thickness
Time frame: Baseline
As measured by Optical Coherence Tomography in different timepoints as an absolute value in micrometers.
2 secondary outcomes
Pattern Electroretinogram Amplitude
Time frame: Baseline
Pattern Electroretinogram Phase
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vittorio Porciattti, DSc principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Latanoprost, Bimatoprost and Travoprost in people with Glaucoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Nerve Fiber Layer Thickness (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.