Multicenter Study on the Efficacy and Safety of OCS-01 in Subjects With Diabetic Macular Edema

• Status: Not yet recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a Phase 3 Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema.

Stage 1 will confirm the safety and efficacy of OCS-01 versus Vehicle alone in subjects with diabetic macular edema (DME).

Stage 2 will evaluate the efficacy and safety of OCS-01 in subjects with DME.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oculis
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria :

1. Have a signed informed consent form before any study-specific procedures are performed;

2. Be a male or female adult subject age 18-75 years. Race and ethnicity information will be collected based on National Institutes of Health criteria.

3. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm (may be adjusted based on gender specific requirements) by SD-OCT at screening (Visit 1) (as assessed by an independent reading center); CST is not part of the eligibility reconfirmation on Day 1.

4. Participants require BCVA ETDRS letter score >34 letters (> 20/200 Snellen equivalent) in the non-study eye at screening (ie, as per definition of monocular blindness).

5. Have an BCVA ETDRS letter score ≤ 65 (Snellen 20/50) and ≥ 24 (Snellen 20/320) in the study eye at screening and baseline (Visit 1 and Visit 2).

6. Have a documented diagnosis of type 1 or type 2 diabetes mellitus and a glycosylated hemoglobin A1c (HbA1c) of ≤ 12.0% (≤108 mmol/mol) at Visit 1 (Screening).

Exclusion Criteria:

OCULAR

1. Have macular edema considered to be because of a cause other than DME; Note: an eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction;(2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (eg, a taut posterior hyaloid or epiretinal membrane) is 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, uveitis, retinal vein occlusion, or drug toxicity. If the DME consists of circumscribed, focal leakage that the evaluating Investigator believes should be treated with laser and no other treatments, the eye is not eligible to be a study eye.

2. Have a decrease in BCVA because of causes other than DME (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that, in the Investigator's opinion, is likely to be decreasing BCVA by three lines or more (ie, cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).

3. Have significant macular ischemia which would prevent gain in visual acuity in the study eye.

4. Have any other ocular disease that may cause substantial reduction in BCVA, including, retinal detachment, epiretinal membrane, vitreous hemorrhage or fibrosis involving the macula in the study eye, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases.

5. Have active or suspected peri-ocular or ocular infection in the study eye (eg, blepharitis, keratitis, scleritis, or conjunctivitis).

6. Have a history of non-infectious uveitis in the study eye.

7. History of herpetic ocular disease in the study eye.

8. Subjects who plan to continue using contact lenses as a main source of vision correction during the study in the study eye.

9. Subjects who plan to use cosmetic contact lenses in the study eye during the study.

10. History of major intraocular ocular surgery within 3 months including cataract surgery in the study eye.

SYSTEMIC

11. Participants who are currently enrolled in or have participated in any other clinical study involving an investigational product (IP) or device, or in any other type of medical research, within 30 days prior to screening and up to completion of the current study.

12. Systemic corticosteroids (prednisone or methylprednisolone) either oral or injectable are not allowed in the study.

The use of acute inhaled corticosteroids is permissible during the study for up to 14 days.

13. Any prior or concomitant systemic anti-VEGF treatment within 6 months prior to Day 1.