Cystoid Macular Edema, Postoperative, Uveitis Related Cystoid Macular Edema
Conditions
Keywords
Cystoid Macular Edema, Uveitis, Postoperative cystoid macular edema, Dexamethasone, Retinal diseases, Anti-Inflammatory Agents
Brief 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. 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.
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.
Interventions
DRUGOCS-01
One drop of OCS-01 eye drops, 3-6 times daily. Dosing frequency will depend on the phase of the study.
Sponsors
Global Ophthalmic Research Center (GORC)
Oculis
Quan Dong Nguyen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
BCVA examiner and study subjects will be masked
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older. 2. Diagnosis of Uveitic macular edema (UME) or post-surgical macular edema (PSME). 3. Can provide written informed consent prior to any study procedure being performed, able and willing to follow all instructions, and attend all study visits. 4. 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. 5. An ETDRS BCVA letter score ≤ 70 (Snellen 20/40) and ≥ 35 (Snellen 20/200) in the study eye at baseline (Visit 2). 6. A documented diagnosis of inactive/stable uveitis (for UME) at the screening visit. 7. 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.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Subfield Thickness | Baseline to 12 weeks | Mean change in central subfield thickness (CST) on optical coherence tomography (OCT) at week 12 compared to baseline. |
| Visual Acuity | Baseline to 12 weeks | Mean change in early treatment of diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) letter score at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in macular leakage | Baseline, week 12 and 24 weeks | Percentage of subjects showing change in macular leakage on fluorescein angiography (FA) at week 12 and 24 compared to baseline |
| Visual function and quality of life | Baseline, week 12 and week 24 | 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. |
| Change in visual acuity | Baseline to 24 weeks | Mean change in ETDRS BCVA letters at weeks 2, 4, 6, 8, 16, 20 and 24 compared to baseline. |
| Central Subfield Thickness | Baseline to week 24 | Mean change in CST as assessed by SD-OCT at weeks 2, 4, 6, 8, 16, 20, 24 compared to baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in BCVA | Weeks 8, 12 and 24 | Percentage of subjects who lose ≥15 ETDRS letters or more at weeks 8, 12, and 24 compared to baseline |
| Change in intraocular pressure from baseline | 8, 12 and 24 weeks | Monitoring of intraocular pressure |
| Adverse effects | Weeks 8, 12 and 24 | Participants will be directly asked at every visit during the drug exposure. In addition a contact number will be provided to the subjects to call if they experience any adverse affect or if they suspect adverse effect at any time between specific visits. |
Countries
United States
Outcome results
None listed