RECRUITING

Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

Conditions

Center Involved Diabetic Macular Edema Diabetic Macular Edema anti-VEGF Transferrin Tumstatin DME

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema

Quick Facts

Study Start:2024-01-13

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05802329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus 2. Decreased visual acuity attributable primarily to DME 3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of: 1. ≥ 320 if male or ≥ 305 µm if female on Heidelberg Spectralis 2. ≥ 305 if male or ≥ 290 if female on Zeiss Cirrus 3. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart 4. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging 5. No history of prior anti-VEGF injection for treatment of DME or history of at least 2 consecutive anti-VEGF intravitreal injection	1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage) 2. Uncontrolled hypertension 3. Uncontrolled glaucoma 4. Concurrent disease in the study eye, other than central-involved DME 5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit 6. Any ocular surgery within 3 months prior to the screening visit in the study eye 7. Uncontrolled/poorly controlled diabetes 8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye 9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit 10. Presence of any inherited retinal disease or proliferative diabetic retinopathy

Inclusion Criteria

Exclusion Criteria

1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus
2. Decreased visual acuity attributable primarily to DME
3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:
1. ≥ 320 if male or ≥ 305 µm if female on Heidelberg Spectralis
2. ≥ 305 if male or ≥ 290 if female on Zeiss Cirrus
3. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
4. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
5. No history of prior anti-VEGF injection for treatment of DME or history of at least 2 consecutive anti-VEGF intravitreal injection

1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
2. Uncontrolled hypertension
3. Uncontrolled glaucoma
4. Concurrent disease in the study eye, other than central-involved DME
5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
6. Any ocular surgery within 3 months prior to the screening visit in the study eye
7. Uncontrolled/poorly controlled diabetes
8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye
9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
10. Presence of any inherited retinal disease or proliferative diabetic retinopathy

Contacts and Locations

Study Contact

Roshan A George, MD, MPH

CONTACT

845-664-1505

roshan.george@ocugen.com

Murthy Chavali, PhD

CONTACT

4057144198

murthy.chavali@ocugen.com

Principal Investigator

Huma Qamar, MD, MPH, CMI

STUDY_DIRECTOR

Ocugen

Study Locations (Sites)

Advanced Research LLC

Deerfield Beach, Florida, 33064

United States

Erie Retina Research, LLC

Erie, Pennsylvania, 16507

United States

Retina Consultants of Texas Research Centers

Bellaire, Texas, 77401

United States

Retina Consultants of America

Southlake, Texas, 76092

United States

Gundersen Health System

La Crosse, Wisconsin, 54601

United States

Collaborators and Investigators

Sponsor: Ocugen

Huma Qamar, MD, MPH, CMI, STUDY_DIRECTOR, Ocugen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-13

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2024-01-13

Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

anti-VEGF
Transferrin
Tumstatin
DME

Additional Relevant MeSH Terms

Center Involved Diabetic Macular Edema
Diabetic Macular Edema