Diabetic Macular Edema
Conditions
Keywords
Topical ophthalmic suspension, Eye drop
Brief summary
The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS- 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).
Detailed description
A Phase 2/3 Pivotal Double-masked, Randomized, Vehicle-controlled, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Participants with Diabetic Macular Edema Stage 1: To select a dose and dosing regimen for OCS-01 in participants with DME and evaluate the efficacy and safety of OCS-01 as compared to Vehicle in participants with DME. Stage 2: To evaluate the efficacy and safety of OCS-01 as compared to Vehicle at Week 52 in participants with DME.
Interventions
Stage 1: Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 6 weeks (maintenance phase). Stage 2: Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).
DRUGVehicle
Stage 1: Participants will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 6 weeks (maintenance phase). Stage 2: Participant will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).
Sponsors
Oculis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
(selection) - Stage 1: 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus at Visit 1 (Screening). Inclusion Criteria (selection) - Stage 2: 1. Have a signed informed consent form before any study-specific procedures are performed. 2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center). 3. Have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1 (Screening).
Exclusion criteria
(selection) - Stage 1 and Stage 2: 1. Have macular edema considered to be because of a cause other than DME. 2. Have a decrease in BCVA because of causes other than DME. 3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in BCVA (Best Corrected Visual Acuity) | Week 52 | Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with a 3-line or Greater Gain in BCVA | Baseline, Week 52 | BCVA will be assessed by ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity. |
| Mean Change in BCVA | Baseline, Week 12 and Week 24 | BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity. |
| Mean Change in Central Subfield Thickness (CST) | Baseline, Week 52 | CST will be measured by SD-OCT. |
Countries
Hong Kong, India, Taiwan, United States
Contacts
PRINCIPAL_INVESTIGATORVeeral S Sheth, MD
University Retina - Lemont
Outcome results
None listed