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Carbonic Anhydrase Inhibitor
Pressure-Lowering Eye Drops for Glaucoma (STOP-RGCD Trial)
Phase 3
Waitlist Available
Led By Vittorio Porciattti, DSc
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 to 85 years, inclusive
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 years
Awards & highlights
STOP-RGCD Trial Summary
This trial will study whether a retinal ganglion cell function test can predict which glaucoma suspects will benefit from pressure-lowering eye drops.
Who is the study for?
This trial is for adults aged 18-85 who are at risk for glaucoma but currently have normal vision. They should have certain eye conditions like a specific optic disc appearance or family history of glaucoma, and not be on pressure-lowering meds. Excluded are those with other major eye diseases, systemic conditions like diabetes or MS, pregnant/nursing women, or anyone unable to follow the study protocol.Check my eligibility
What is being tested?
The study tests if pressure-lowering eye drops can prevent retinal ganglion cell dysfunction in people at risk for glaucoma. Participants with abnormal retina function will receive one of several eye drop treatments; others won't be treated but monitored over four years using noninvasive tests like PERG and OCT.See study design
What are the potential side effects?
Potential side effects from the eye drops may include mild stinging upon application, redness in the eyes, changes in eyelash growth or coloration, darkening of skin around the eyes, blurred vision temporarily after use, and occasionally more serious effects that could affect heart rate or breathing.
STOP-RGCD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 85 years old.
STOP-RGCD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in retinal nerve fiber layer thickness
Secondary outcome measures
Change in Pattern Electroretinogram Amplitude
Change in Pattern Electroretinogram Phase
Side effects data
From 2021 Phase 3 trial • 485 Patients • NCT038253806%
Conjunctival hyperaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
T4032
Lumigan®
STOP-RGCD Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Abnormal PERG TreatedExperimental Treatment8 Interventions
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.
Group II: Abnormal PERG UntreatedActive Control1 Intervention
Participants recognized as Glaucoma suspects with an abnormal PERG test who have been assigned to not receive therapy or intervention.
Group III: NormalActive Control1 Intervention
Patients with a normal PERG test that will go through the study under observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Latanoprost
FDA approved
Bimatoprost
FDA approved
Travoprost
FDA approved
Timolol
FDA approved
Dorzolamide
FDA approved
Methazolamide
FDA approved
Acetazolamide
FDA approved
Find a Location
Who is running the clinical trial?
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,428 Total Patients Enrolled
41 Trials studying Glaucoma
12,901 Patients Enrolled for Glaucoma
University of MiamiLead Sponsor
898 Previous Clinical Trials
409,151 Total Patients Enrolled
9 Trials studying Glaucoma
1,902 Patients Enrolled for Glaucoma
Vittorio Porciattti, DScPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I might have glaucoma based on certain signs.You have thinning of the disc in a specific area.I am taking prescribed medication to lower my pressure and cannot stop.I am at risk for glaucoma based on eye examination results or family history.I am between 18 and 85 years old.My family has a history of vision loss due to glaucoma.My eye condition shows a significant cupping in the optic nerve.My eye condition shows significant optic nerve damage.I am willing and able to follow the study's requirements.I have age-related macular degeneration.I have multiple sclerosis.I have diabetes.I have Parkinson's disease.
Research Study Groups:
This trial has the following groups:- Group 1: Abnormal PERG Untreated
- Group 2: Abnormal PERG Treated
- Group 3: Normal
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people of all ages welcome to participate in this research project?
"According to the eligibility criteria, patients that fall between 18 to 85 years old may apply to be a part of this trial. There are 26 trials for people under 18 and 228 for people 65 and older."
Answered by AI
What medical condition is Bimatoprost typically used to treat?
"Salicylate intoxication is most commonly treated using Bimatoprost. However, Bimatoprost can also be used to effectively reduce symptoms in patients with conditions like edema, glaucoma, suspect, and open angle glaucoma (oag)."
Answered by AI
What are some other ways that Bimatoprost has been studied in a clinical setting?
"Right now, there are 40 Bimatoprost studies underway. 13 of those are in the critical Phase 3 stage. The majority of these studies are based in Pittsburgh, although there are 538 total locations running these trials."
Answered by AI
Has Bimatoprost undergone extensive testing by the FDA?
"Bimatoprost is estimated to be a safe medication as it has gone through multiple rounds of clinical trials, receiving a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Bascom Palmer Eye Institute - University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Phone Call
Most responsive sites:
- Bascom Palmer Eye Institute - University of Miami: < 24 hours
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