JV-GL1 for Glaucoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, JV-GL1, to determine its safety and effectiveness in lowering eye pressure in individuals with open-angle glaucoma or ocular hypertension. Researchers aim to assess whether this treatment can better manage these conditions. The trial compares different doses of JV-GL1 to identify the most effective one. Individuals diagnosed with open-angle glaucoma or high eye pressure in both eyes might be suitable candidates. As a Phase 1 trial, participants could be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that JV-GL1 is safe for lowering eye pressure. Studies in dogs have demonstrated that JV-GL1 is a safe treatment for glaucoma, a condition where the eye's nerve is damaged, and it does not cause harm when used to reduce eye pressure. Another study found that a single dose of JV-GL1 significantly lowered eye pressure in non-human primates for about a week, without any dose-related side effects.
These findings suggest that JV-GL1 is well-tolerated in both animals and humans, which is promising for its safety in treating open-angle glaucoma or high eye pressure. However, since the trial remains in the early stages, monitoring for any possible side effects is important.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for open-angle glaucoma and ocular hypertension, which typically focus on reducing intraocular pressure with medications like beta-blockers or prostaglandin analogs, JV-GL1 offers a unique approach. Researchers are excited about JV-GL1 because it potentially targets the disease pathway differently, offering a novel mechanism of action that could improve outcomes for patients. Additionally, JV-GL1 might provide a more personalized treatment option with its different dosages being tested, which could lead to better efficacy and safety profiles compared to existing therapies.
What evidence suggests that this trial's treatments could be effective for lowering intraocular pressure?
Research has shown that JV-GL1 is a promising treatment for reducing eye pressure in people with open-angle glaucoma or high eye pressure. In this trial, participants will receive either JV-GL1 or Latanoprost 0.005% Ophthalmic Solution. Studies have demonstrated that a 0.01% dose of JV-GL1 lowered eye pressure more effectively than some current treatments, such as bimatoprost at 0.03%. This suggests that JV-GL1 could be a strong option for managing eye pressure. Additionally, JV-GL1 proved effective for several days in animal studies, indicating it could be a long-lasting treatment. These findings offer hope for those seeking better management of their eye conditions.23567
Who Is on the Research Team?
David Wirta, MD
Principal Investigator
Eye Research Foundation, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Part 1 of the study is a dose escalation, sequentially testing escalating doses of JV-GL1
Treatment
Part 2 of the study will be randomized, treating subjects at selected JV-GL1 doses or Latanoprost for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JV-GL1
- Latanoprost 0.005% Ophthalmic Solution
Find a Clinic Near You
Who Is Running the Clinical Trial?
JeniVision, Inc.
Lead Sponsor