OCU200 for Diabetic Macular Edema

(DME Trial)

Recruiting at 4 trial locations

Overseen By Murthy Chavali, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ocugen

Must not be taking: Steroids

Disqualifiers: Uncontrolled hypertension, Glaucoma, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

28 Participants Needed

Trial Summary

What is the purpose of this trial?

A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does mention that you should not have had steroid treatments or certain eye surgeries in the last 3 months.

What data supports the effectiveness of the drug OCU200 for treating diabetic macular edema?

Research shows that treatments like ranibizumab and dexamethasone, which are used for similar eye conditions, have been effective in reducing macular edema (swelling in the eye). This suggests that OCU200, which may work in a similar way, could also be effective for diabetic macular edema. ^{1 2 3 4 5}

How is the drug OCU200 different from other treatments for diabetic macular edema?

OCU200 is unique because it offers multiple dosing options (high, medium, and low), which may allow for more personalized treatment compared to standard therapies like dexamethasone implants or ranibizumab injections that typically have fixed dosages. ^{2 4 6 7 8}

Research Team

Huma Qamar, MD, MPH, CMI

Principal Investigator

Ocugen

Eligibility Criteria

This trial is for adults with diabetic macular edema, a type of eye swelling. They must have certain levels of retinal thickness and vision range (20/32 to 20/320). Participants should not have had recent anti-VEGF injections unless they didn't fully work.

Inclusion Criteria

I haven't had anti-VEGF injections for DME, or they didn't fully work.

My eye thickness measurement is above the required level.

My eye test score is above the required threshold.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation Treatment

Participants receive intravitreal injections of OCU200 at varying doses (low, medium, high) to assess safety and efficacy

20 weeks

Multiple visits for dosing and monitoring

Combination Therapy Treatment

Participants receive OCU200 (High Dose or MTD) in combination with Lucentis

20 weeks

Sequential dosing visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

Treatment Details

Interventions

• OCU200 High Dose
• OCU200 Low Dose
• OCU200 Medium Dose

Trial Overview The study tests three doses of OCU200 to see how safe and effective it is for treating center-involved diabetic macular edema. It's a Phase I trial, which means it's an early step in testing the drug on people.

Participant Groups

Group I: Cohort 4 (High Dose/MTD + Lucentis) Experimental Treatment 1 Intervention

3 + 3 additional participants will be enrolled to receive OCU200 (High Dose or MTD) + Lucentis (in a sequential manner on dosing dates).

Group II: Cohort 3 (High Dose) Experimental Treatment 1 Intervention

3+3 participants will receive intravitreal injection of OCU200 high dose concentration.

Group III: Cohort 2 (Medium Dose) Experimental Treatment 1 Intervention

3+3 participants will receive intravitreal injection of OCU200 medium dose concentration.

Group IV: Cohort 1 (Low Dose) Experimental Treatment 1 Intervention

3+3 participants will receive intravitreal injection of OCU200 low dose concentration.

Who Is Running the Clinical Trial?

Ocugen

Lead Sponsor

Trials

12

Recruited

1,100+

Findings from Research

In a study of 78 patients with diabetic macular edema, a single intravitreal implant of dexamethasone (Ozurdex®) led to a significant reduction in central retinal thickness by an average of 145.2 µm and an improvement in best-corrected visual acuity by 6.7 letters after 6 months.

The treatment was generally safe, with only 11.7% of patients experiencing increased intraocular pressure, all of which were effectively managed with topical treatment, and no serious complications like glaucoma or endophthalmitis reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intravitreal Dexamethasone Implant in Patients with Diabetic Macular Edema. Guigou, S., Pommier, S., Meyer, F., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Intravitreal dexamethasone implant in radiation-induced macular oedema. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

DEXAMETHASONE INTRAVITREAL IMPLANT VS RANIBIZUMAB IN THE TREATMENT OF MACULAR EDEMA SECONDARY TO BRACHYTHERAPY FOR CHOROIDAL MELANOMA. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Two-year results for ranibizumab for radiation retinopathy (RRR): a randomized, prospective trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Intravitreal ranibizumab and dexamethasone implant injections as primary treatment of diabetic macular edema: simultaneously double protocol. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Treatment of radiation-induced maculopathy with fluocinolone acetonide. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Geographic pattern of central retinal sensitivity after intravitreal triamcinolone for diabetic macular edema. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intravitreal Dexamethasone Implant in Patients with Diabetic Macular Edema. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A prospective randomised controlled clinical trial comparing a combination of repeated intravitreal Ozurdex and macular laser therapy versus macular laser only in centre-involving diabetic macular oedema (OZLASE study). [2017]