OCU200 for Diabetic Macular Edema

(DME Trial)

Recruiting at 4 trial locations

Overseen By Oscar Cuzzani, MD, 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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called OCU200 for diabetic macular edema, a condition causing vision problems due to retinal swelling. Researchers are testing different doses of OCU200 to assess its safety and effectiveness. Individuals with diabetes and vision issues from this condition may be suitable for the trial, particularly if other treatments have been ineffective. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that OCU200 is generally safe for people with diabetic macular edema. In earlier studies, most participants handled the treatment well. About 11.7% of patients experienced increased eye pressure, which was controlled with eye drops. The Data and Safety Monitoring Board reviewed the safety information and allowed the treatment to continue, indicating confidence in its safety. Thus, OCU200 is considered safe enough for further testing in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for diabetic macular edema, which often involve anti-VEGF drugs like Lucentis that target blood vessel growth, OCU200 offers a novel approach. This investigational treatment is unique because it employs a different mechanism, potentially targeting multiple pathways involved in the disease's progression. Researchers are particularly excited about the potential for OCU200 to be administered in varying doses, which could optimize its effectiveness and safety. Additionally, the combination of OCU200 with existing treatments like Lucentis could enhance overall outcomes, offering new hope for improved vision preservation.

What evidence suggests that this trial's treatments could be effective for diabetic macular edema?

Research shows that OCU200, a new treatment, may help with diabetic macular edema (DME), a condition that causes swelling in the eye. OCU200 combines two proteins, tumstatin and transferrin, which might help reduce this swelling. Early safety reviews indicate that patients tolerate the treatment well. This trial tests different doses of OCU200 to find the most effective one. Although still in early stages, the mechanism of OCU200 offers hope for managing DME symptoms. ^{1 2 4 5 6}

Who Is on the Research Team?

Huma Qamar, MD, MPH, CMI

Principal Investigator

Ocugen

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Cohort 5 Experimental Treatment 1 Intervention

MTD + Lucentis: 3+3 participants will receive intravitreal injection of OCU200 (MTD) + Lucentis

Group II: Cohort 4 Experimental Treatment 1 Intervention

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

Group III: Cohort 3 Experimental Treatment 1 Intervention

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

Group IV: Cohort 2 Experimental Treatment 1 Intervention

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

Group V: Cohort 1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Ocugen

Lead Sponsor

Trials

12

Recruited

1,100+

Published Research Related to This Trial

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]

Citations

1. ir.ocugen.com ir.ocugen.com/news-releases/news-release-details/data-and-safety-monitoring-board-reviews-cohort-1-safety-data

Press Release - Investors - Ocugen OCU200 is a novel fusion protein consisting of two human proteins, tumstatin and transferrin, with the potential to treat diabetic macular edema (DME).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05802329

Phase I Study to Assess the Safety and Efficacy of OCU200 ... Study Overview. Brief Summary. A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema.

3. withpower.com withpower.com/trial/phase-1-macular-edema-3-2023-4e9ea

OCU200 for Diabetic Macular Edema (DME Trial) 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 ...

4. ophthalmologytimes.com ophthalmologytimes.com/view/ocugen-to-move-forward-with-dosing-of-second-cohort-of-phase-1-clinical-trial-of-ocu200

Ocugen to move forward with dosing of second cohort ... After review by the Data and Safety Monitoring Board, the dosing of OCU200 in patients with diabetic macular edema (DME) will continue.

5. ir.ocugen.com ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-first-patient-dosed-phase-1-clinical-trial

Press Release - Investors - Ocugen The OCU200 Phase 1 clinical trial is a multicenter, open-label, dose-escalation study to assess drug safety via intravitreal injection in three cohorts.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05802329/phase-i-study-to-assess-the-safety-and-efficacy-of-ocu200-for-center-involved-diabetic-macular-edema-dme

Phase I Study to Assess the Safety and Efficacy of OCU200 ... A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema.