28 Participants Needed

OCU200 for Diabetic Macular Edema

(DME Trial)

Recruiting at 4 trial locations
HQ
BS
SS
RA
MC
Overseen ByMurthy Chavali, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.14678

Who Is on the Research Team?

HQ

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.
See 2 more

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?
4Treatment groups
Experimental Treatment
Group I: Cohort 4 (High Dose/MTD + Lucentis)Experimental Treatment1 Intervention
Group II: Cohort 3 (High Dose)Experimental Treatment1 Intervention
Group III: Cohort 2 (Medium Dose)Experimental Treatment1 Intervention
Group IV: Cohort 1 (Low Dose)Experimental Treatment1 Intervention

Find a Clinic Near You

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

Citations

Intravitreal dexamethasone implant in radiation-induced macular oedema. [2018]
DEXAMETHASONE INTRAVITREAL IMPLANT VS RANIBIZUMAB IN THE TREATMENT OF MACULAR EDEMA SECONDARY TO BRACHYTHERAPY FOR CHOROIDAL MELANOMA. [2018]
Two-year results for ranibizumab for radiation retinopathy (RRR): a randomized, prospective trial. [2022]
Intravitreal ranibizumab and dexamethasone implant injections as primary treatment of diabetic macular edema: simultaneously double protocol. [2021]
Treatment of radiation-induced maculopathy with fluocinolone acetonide. [2021]
Geographic pattern of central retinal sensitivity after intravitreal triamcinolone for diabetic macular edema. [2022]
Efficacy and Safety of Intravitreal Dexamethasone Implant in Patients with Diabetic Macular Edema. [2022]
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]
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