Uveitis Related Cystoid Macular EdemaPhase 2LEOPARDNCT05608837

Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Uveitis Related and Post Surgical Macular Edema

A Phase 2 study testing OCS-01 in people with Uveitis Related Cystoid Macular Edema and Cystoid Macular Edema, Postoperative, run by Quan Dong Nguyen at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The goal of the LEOPARD clinical trial is to investigate a new kind of steroid eye drops, OCS-01. Macular edema is a condition in which there is collection of fluid (edema) in the back of the eye (Macula) and it can lead to severe loss of vision. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
What is being tested?: OCS-01
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 8 sitesUnited States
Study dates: 26 May 2023to Oct 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older.
Diagnosis of Uveitic macular edema (UME) or post-surgical macular edema (PSME).
Can provide written informed consent prior to any study procedure being performed, able and willing to follow all instructions, and attend all study visits.
UME of less than 1 years in duration or PSME of less than 1 year, with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥ 320 µm by SD-OCT at baseline (as measured by the central reading center employing Heidelberg Spectralis spectral domain optical coherence tomography, SD-OCT). Note: Recurrent CME is also eligible if the current episode is of less than 1 year.
An ETDRS BCVA letter score ≤ 70 (Snellen 20/40) and ≥ 35 (Snellen 20/200) in the study eye at baseline (Visit 2).
A documented diagnosis of inactive/stable uveitis (for UME) at the screening visit.
A trial of topical NSAID or topical corticosteroids (for PSME) for at least one consecutive month but less than 3 consecutive months before screening visit with documented treatment failure on SD-OCT or based on investigator's clinical evaluation.
Note: If both eyes are eligible, the eye with the worse BCVA will be selected as the study eye. If both eyes have the same BCVA, the non-dominant eye will be selected.

Who cannot join

Subjects who meet any of the following exclusion criteria will not be included in the study
Macular edema considered to be due to a cause other than UME or PSME. An eye is not considered eligible if: (1) the macular edema is considered to be related to diabetes (2) clinical exam and/or OCT suggests that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema, or (3) the macular edema is considered to be related to another condition such as age-related macular degeneration, retinal vein occlusion, or drug toxicity.
A decrease in BCVA due to causes other than UME or PSME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that are likely to decrease BCVA by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
Use of other ophthalmic formulations during the study. However, intraocular pressure (IOP) lowering eye drops are allowed if they become necessary due to increased IOP.
History of glaucoma and documented glaucomatous optic neuropathy or clinically significant ocular hypertension in the opinion of the investigator, involving an IOP ≥ 25 mmHg on > 3 anti-glaucoma medications in the study eye.
Any other ocular disease that could cause substantial reduction in BCVA, including retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis involving the macula in the study eye, other retinal inflammatory or infectious diseases.

Show all 19Show fewer

Active peri-ocular or ocular infection (e.g., blepharitis, keratitis, scleritis, or conjunctivitis).
History of infectious uveitis.
High myopia (-8 diopter or more correction) in the study eye.
Any form of diabetic retinopathy.
History of increased intraocular pressure with topical steroid therapy.
Pregnancy/Breastfeeding
For UME:
Active uveitis as determined by the presence of anterior chamber cells or vitreous cells.
Unstable (increasing) dose of immunosuppressives during 2 months prior to the baseline visit. Immunosuppressives are defined as antimetabolites (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine and tacrolimus, among others) and biologics (including adalimumab, infliximab, tocilizumab, golimumab, secukinumab and rituximab, and others).
Treated with more than 2 types of immunosuppressives (excluding steroids) within 2 months prior to baseline visit.
Unstable (increasing) dose of oral prednisone for 1 month before baseline visit.
Oral prednisone therapy at dose > 10 mg daily (or equivalent) within 1 month prior to baseline visit.
History of contact lens use within 2 weeks prior to baseline or at any time during the study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Massachusetts Eye Research and Surgery Institution
Boston, Massachusetts, 02451
Erie Retina Research
Erie, Pennsylvania, 16507
Retina Associates of Southern California
Huntington Beach, California, 92647
Stein Eye Institute at UCLA
Los Angeles, California, 90095
Valley Retina Institute P.A
McAllen, Texas, 78503
Byers Eye Institute at Stanford
Palo Alto, California, 94303
Texas Retina Associates
Plano, Texas, 75075

Other trials in United States

About this study

Official title: Efficacy and Safety of Dexamethasone ophthaLmic Suspension Eye drOps in Uveitic and Post Surgical mAculaR eDema (The LEOPARD Study)

The goal of the LEOPARD clinical trial is to investigate a new kind of steroid eye drops, OCS-01.

Macular edema is a condition in which there is collection of fluid (edema) in the back of the eye (Macula) and it can lead to severe loss of vision. Among other causes, macular edema can happen because of a disease of the eye called Uveitis, and also after eye surgery. Treatment of macular edema remains a challenge as the condition may persist for several months and may lead to irreversible changes in the eye and poor vision.

In the LEOPARD study the investigators wish to see how safe is the study drug (OCS-01) and how well it works, in resolving the fluid collection in the eye in patients with Uveitis or in patients who have had eye surgery.

Participants will undergo detailed eye exam, and record their eye and medical history to see what their disease status is and if they can be included in the study based on the study criteria. If included, they will take the study drug OCS-01 in different doses for 24 weeks. During the study period, they will have regular eye exams to ensure their safety and to assess the usefulness of the study drug.

Read the detailed description

LEOPARD is a prospective, multi-center, single masked, randomized, controlled, study. At least 24 eligible subjects (12 with Uveitic macular edema and 12 with Post surgical macular edema) are to be enrolled in the study. There will be at least 5 sites and the total treatment period is 24 weeks.

The study will consist of 4 phases: Screening Phase, Loading Phase, Treatment Phase and Follow-up Phase. Subjects will receive their assigned treatments until week 04, get randomized into groups and continue their assigned treatments until week 12. Primary endpoint assessments will be performed at week 12.

From week 12 to week 24, if there is still edema as demonstrated on OCT, subjects will receive treatment based on the retreatment criteria.

Conditions: Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
Being tested: OCS-01
Keywords: Cystoid Macular Edema, Uveitis, Postoperative cystoid macular edema, Dexamethasone, Retinal diseases, Anti-Inflammatory Agents
Medical subject headings: Macular Edema, Uveitis, Retinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OCS-01Drug
Also called dexamethasone ophthalmic suspension eye drops
One drop of OCS-01 eye drops, 3-6 times daily. Dosing frequency will depend on the phase of the study.

Study groups in NCT05608837
Study group	Role	What they receive
High Dose UME - 6 drops OCS-01	Experimental	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. Receives: Drug: OCS-01
Low Dose UME 3 drops OCS-01 and 3 drops Placebo	Experimental	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. Receives: Drug: OCS-01
High dose PSME - 6 drops of OCS-01	Experimental	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. Receives: Drug: OCS-01
Low dose PSME - 3 drops of OCS-01 and 3 drops of Placebo	Experimental	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. Receives: Drug: OCS-01

What is being measured

The primary outcome is the main question the study is designed to answer.

Central Subfield Thickness
Mean change in central subfield thickness (CST) on optical coherence tomography (OCT) at week 12 compared to baseline.
Measured: Baseline to 12 weeks
Visual Acuity
Mean change in early treatment of diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score at week 12
Measured: Baseline to 12 weeks

Secondary outcomes (5)

Change in visual acuity
Mean change in ETDRS BCVA letters at weeks 2, 4, 6, 8, 16, 20 and 24 compared to baseline.
Measured: Baseline to 24 weeks
Change in visual acuity
The percentage of subjects who gain ≥10 or ≥15 ETDRS letters at week 12 and 24 compared to baseline.
Measured: Week 12 and 24
Central Subfield Thickness
Mean change in CST as assessed by SD-OCT at weeks 2, 4, 6, 8, 16, 20, 24 compared to baseline.
Measured: Baseline to week 24
Visual function and quality of life
Improvement in quality of life as assessed by National Eye Institute Visual Function Questionnaire (NEI VFQ-25) at Week 12, and 24 compared to baseline.
Measured: Baseline, week 12 and week 24
Change in macular leakage
Percentage of subjects showing change in macular leakage on fluorescein angiography (FA) at week 12 and 24 compared to baseline
Measured: Baseline, week 12 and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 2023Oct 2026

First posted8 Nov 2022
Study start26 May 2023
Primary completionOct 2026 (estimated)
Study completionOct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Uveitis Related Cystoid Macular EdemaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05608837
Sponsor's protocol ID: 66881
Acronym: LEOPARD
Status last verified: Oct 2026
First submitted: 1 Nov 2022
Last updated: 2 Nov 2026
Results posted: 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Dexamethasone ophthaLmic Suspension Eye drOps in Uveitic and Post Surgical mAculaR eDema (The LEOPARD Study)
ClinicalTrials.gov ID: NCT05608837
Acronym / sponsor ID: LEOPARD / 66881
Conditions: Uveitis Related Cystoid Macular Edema, Cystoid Macular Edema, Postoperative
Keywords: Cystoid Macular Edema, Uveitis, Postoperative cystoid macular edema, Dexamethasone, Retinal diseases, Anti-Inflammatory Agents
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 28 participants (actual)
Lead sponsor: Quan Dong NguyenUniversity, hospital or other
Collaborators: Global Ophthalmic Research Center (GORC), Oculis
Study start: 26 May 2023 (actual)
Primary completion: Oct 2026 (estimated)
Study completion: Oct 2026 (estimated)
First posted: 8 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of the LEOPARD clinical trial is to investigate a new kind of steroid eye drops, OCS-01.

Detailed description

From week 12 to week 24, if there is still edema as demonstrated on OCT, subjects will receive treatment based on the retreatment criteria.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
High Dose UME - 6 drops OCS-01	Experimental	Drug: OCS-01From 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.
Low Dose UME 3 drops OCS-01 and 3 drops Placebo	Experimental	Drug: OCS-01From 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.
High dose PSME - 6 drops of OCS-01	Experimental	Drug: OCS-01From 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.
Low dose PSME - 3 drops of OCS-01 and 3 drops of Placebo	Experimental	Drug: OCS-01From 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18 years or older.
Diagnosis of Uveitic macular edema (UME) or post-surgical macular edema (PSME).
Can provide written informed consent prior to any study procedure being performed, able and willing to follow all instructions, and attend all study visits.
UME of less than 1 years in duration or PSME of less than 1 year, with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥ 320 µm by SD-OCT at baseline (as measured by the central reading center employing Heidelberg Spectralis spectral domain optical coherence tomography, SD-OCT). Note: Recurrent CME is also eligible if the current episode is of less than 1 year.
An ETDRS BCVA letter score ≤ 70 (Snellen 20/40) and ≥ 35 (Snellen 20/200) in the study eye at baseline (Visit 2).

Key exclusion criteria (19 listed)

Subjects who meet any of the following exclusion criteria will not be included in the study
Macular edema considered to be due to a cause other than UME or PSME. An eye is not considered eligible if: (1) the macular edema is considered to be related to diabetes (2) clinical exam and/or OCT suggests that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema, or (3) the macular edema is considered to be related to another condition such as age-related macular degeneration, retinal vein occlusion, or drug toxicity.
A decrease in BCVA due to causes other than UME or PSME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that are likely to decrease BCVA by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).
Use of other ophthalmic formulations during the study. However, intraocular pressure (IOP) lowering eye drops are allowed if they become necessary due to increased IOP.
History of glaucoma and documented glaucomatous optic neuropathy or clinically significant ocular hypertension in the opinion of the investigator, involving an IOP ≥ 25 mmHg on > 3 anti-glaucoma medications in the study eye.

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
OCS-01Also: dexamethasone ophthalmic suspension eye dropsOne drop of OCS-01 eye drops, 3-6 times daily. Dosing frequency will depend on the phase of the study.	Drug	High Dose UME - 6 drops OCS-01, High dose PSME - 6 drops of OCS-01, Low Dose UME 3 drops OCS-01 and 3 drops Placebo, Low dose PSME - 3 drops of OCS-01 and 3 drops of Placebo

Primary outcome

Central Subfield Thickness
Time frame: Baseline to 12 weeks
Mean change in central subfield thickness (CST) on optical coherence tomography (OCT) at week 12 compared to baseline.
Visual Acuity
Time frame: Baseline to 12 weeks
Mean change in early treatment of diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score at week 12

5 secondary outcomes

Change in visual acuity
Time frame: Baseline to 24 weeks
Change in visual acuity
Time frame: Week 12 and 24
Central Subfield Thickness
Time frame: Baseline to week 24
Visual function and quality of life
Time frame: Baseline, week 12 and week 24
Change in macular leakage
Time frame: Baseline, week 12 and 24 weeks

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Individual participant dataSharing planned: No

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.

Quan D Nguyen, MD, MSc study chair

Stanford University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OCS-01 in people with Uveitis Related Cystoid Macular Edema and Cystoid Macular Edema, Postoperative, run by Quan Dong Nguyen at 8 sites 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 8 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Central Subfield Thickness (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05608837.

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 2 Nov 2026.