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Corticosteroid
OCS-01 for Macular Edema (LEOPARD Trial)
Phase 2
Recruiting
Research Sponsored by Quan Dong Nguyen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 8, 12 and 24
Awards & highlights
LEOPARD Trial Summary
This trial is studying a new kind of steroid eye drops to see if it can help those with macular edema due to Uveitis or eye surgery.
Who is the study for?
Adults over 18 with Uveitic macular edema (UME) or post-surgical macular edema (PSME), who have had the condition for less than 3 years (UME) or less than 1 year (PSME). Participants must have a certain level of vision impairment and be able to attend all study visits. Those with macular edema due to other causes, significant eye diseases, high myopia, history of steroid-induced increased eye pressure, active infections, pregnancy/breastfeeding, unstable uveitis or immunosuppressive treatment are excluded.Check my eligibility
What is being tested?
The LEOPARD trial is testing OCS-01 steroid eye drops' safety and effectiveness in treating fluid buildup in the back of the eye caused by UVE or following surgery. Patients will use different doses for 24 weeks while undergoing regular detailed eye exams to monitor their response and any side effects.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects from similar steroid treatments may include increased intraocular pressure which can lead to glaucoma if persistent; cataract formation; potential for secondary infection; discomfort at application site; blurred vision temporarily after administration.
LEOPARD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8, 12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8, 12 and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Visual Acuity
Secondary outcome measures
Central Subfield Thickness
Change in macular leakage
Body Weight Changes
+1 moreOther outcome measures
Adverse effects
Change in BCVA
Body Weight Changes
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
LEOPARD Trial Design
4Treatment groups
Experimental Treatment
Group I: Low dose PSME - 3 drops of OCS-01 and 3 drops of PlaceboExperimental Treatment1 Intervention
From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day.
At week 4, the participants randomized to low dose group will receive 01 drop of OCS-01 three times a day and 01 drop of placebo three times a day, (total 6 drops each day) until the primary end point at week 12.
Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24.
Group II: Low Dose UME 3 drops OCS-01 and 3 drops PlaceboExperimental Treatment1 Intervention
From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day.
At week 4, the participants randomized to low dose group will receive 01 drop of OCS-01 three times a day and 01 drop of placebo three times a day,( total 6 drops each day) until the primary end point at week 12.
Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24.
Group III: High dose PSME - 6 drops of OCS-01Experimental Treatment1 Intervention
From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day.
At week 4, participants randomized to the high dose group will continue to receive 01 drop of OCS-01 six times a day until the primary end point at week 12.
Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24.
Group IV: High Dose UME - 6 drops OCS-01Experimental Treatment1 Intervention
From baseline until week 4 all participants will receive 01 drop of OCS-01, six times a day.
At week 4, participants randomized to the high dose group will continue to receive 01 drop of OCS-01 six times a day until the primary end point at week 12.
Starting week 12 the treatment will be administered based on the retreatment criteria until the end of study at week 24.
Find a Location
Who is running the clinical trial?
Quan Dong NguyenLead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
OculisIndustry Sponsor
8 Previous Clinical Trials
1,706 Total Patients Enrolled
Global Ophthalmic Research Center (GORC)UNKNOWN
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My dose of immunosuppressants has not increased in the last 2 months.I can use eye drops for high eye pressure if needed during the study.I have diabetic retinopathy.I have taken more than 10 mg of prednisone daily in the last month.I have an eye condition that significantly lowers my vision.My eye pressure goes up with steroid eye drops.I have had an eye infection called uveitis before.My dose of oral prednisone has been stable for the last month.My macular edema is not caused by UME or PSME.I have an active eye or area around the eye infection.I tried a skin cream for pain or swelling without success for 1 to 3 months.I have active inflammation in my eye.I am 18 years old or older.My vision loss is not mainly due to UME or PSME.My eye condition has lasted less than a year and involves fluid buildup.I have been diagnosed with swelling in the macula due to uveitis or after surgery.If both my eyes qualify, the one with poorer vision or my non-dominant eye will be chosen for the study.I have been treated with more than 2 immunosuppressives in the last 2 months.I have glaucoma with severe optic nerve damage or high eye pressure despite using 3 or more medications.My eye inflammation is currently inactive or stable.
Research Study Groups:
This trial has the following groups:- Group 1: High Dose UME - 6 drops OCS-01
- Group 2: Low Dose UME 3 drops OCS-01 and 3 drops Placebo
- Group 3: High dose PSME - 6 drops of OCS-01
- Group 4: Low dose PSME - 3 drops of OCS-01 and 3 drops of Placebo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What is the maximum number of participants accepted for this clinical trial?
"Confirmatively, clinicaltrials.gov verifies that this investigation is currently seeking volunteers. It was originally posted on the 26th of May 2023 and last updated on 5 June 2023. This trial needs a total of 24 participants from 4 different locations."
Answered by AI
How many venues are currently undertaking this trial?
"Currently, this medical trial is being held at 4 sites, with Palo Alto and McAllen as two of the locales. Plano and four additional destinations are also implementing the study. To avoid extended travel periods while participating in the research, patients should select a nearby clinic to attend."
Answered by AI
What have the findings been in terms of patient safety related to high dose PSME - 6 drops of OCS-01?
"There is a moderate amount of evidence suggesting the safety of High dose PSME - 6 drops of OCS-01, so it was assigned a score of 2. Unfortunately, there are no studies that have established efficacy for this medication yet."
Answered by AI
Is this laboratory research accepting new participants?
"Affirmative. Clinicaltrials.gov has documented that this clinical trial, which was first posted on May 26th 2023, is still actively recruiting participants from 4 different sites with a total of 24 required enrollees."
Answered by AI
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