Center Involved Diabetic Macular EdemaPhase 1DMENCT05802329
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
A Phase 1 study testing OCU200 in people with Center Involved Diabetic Macular Edema and Diabetic Macular Edema, run by Ocugen at 5 sites in United States.
Trial summary
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Center Involved Diabetic Macular Edema, Diabetic Macular Edema
- What is being tested?
- OCU200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Jan 2024to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Decreased visual acuity attributable primarily to DME
- Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:
- ≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis
- ≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus
- BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
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- Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
- No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year.
- Note: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye.
Who cannot join
- Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
- Uncontrolled hypertension
- Uncontrolled glaucoma
- Concurrent disease in the study eye, other than central-involved DME
- Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
- Any ocular surgery within 3 months prior to the screening visit in the study eye
Show all 11Show fewer
- Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)
- History of retinal detachment in the study eye or other retinal vascular disease in the study eye
- Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
- Presence of any inherited retinal disease or history of proliferative diabetic retinopathy
- History of Renal disease including stage 3b or worse
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Oscar Cuzzani, MD, PhD contact
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Retina Consultants of Texas Research Centers
Bellaire, Texas, 77401
Rebecca Taing, 713-394-7576, rebbecca.taing@retinaconsultantstexas.com
Charles Wykoff, MD
- Recruiting
Advanced Research LLC
Deerfield Beach, Florida, 33064
Danahe Navarrete, 954-302-3047 ext. 103, dnavarrete@advancedresearchfl.com
Samarth Shah, MD, Ph.D, sshah@advancedresearchfl.com
- Recruiting
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Bethany Scott, 814-737-0203, b.scott.research@pm.me
David Almeida, MD, MDA, PhD
- Recruiting
Gundersen Health System
La Crosse, Wisconsin, 54601
Trinity Lee, 608-775-9539, trinity.lee@emplifyhealth.org
Chase Penzkover, chase.penzkover@emplifyhealth.org
- Recruiting
Retina Consultants of America
Southlake, Texas, 76092
Lydia Adams, 800-833-5921, lydia.adams@retinaconsultantstexas.com
Emily Gonzales, emily.gonzales@retinaconsultantstexas.com
About this study
Official title: A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Read the detailed description
This is a multicenter, open-label, dose ranging study with 4 cohorts in the dose-escalation portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used.
Under the escalation design, 12 subjects will be enrolled if there are no DLTs and up to 24 subjects under the condition that exactly 1 of the 3 subjects of every cohort if determined to have a DLT.
Each subject will receive a total of 2 intravitreal injections of OCU200 6 weeks apart.
The DSMB will review the sentinel subject 1 week safety data post dosing in every cohort of all 3 subjects.
Cohort 1: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 2: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 3: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 4: 3+3 participants will receive intravitreal injection of OCU200.
- Being tested
- OCU200
- Keywords
- anti-VEGF, Transferrin, Tumstatin, DME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCU200Drug
Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 3+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration). Receives: Drug: OCU200 |
| Cohort 2 | Experimental | 3+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration). Receives: Drug: OCU200 |
| Cohort 3 | Experimental | 3+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration). Receives: Drug: OCU200 |
| Cohort 4 | Experimental | 3+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration). Receives: Drug: OCU200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Drug-related adverse events (SDAE)
Counts, frequencies and percentages of SDAEs.
Measured: 24 weeks
Treatment-emergent adverse events (TEAEs)
Counts, frequencies and percentages TEAEs.
Measured: 24 weeks
Serious adverse events (SAEs)
Counts, frequencies and percentages of SAEs.
Measured: 24 weeks
Secondary outcomes (6)
Best-corrected visual acuity (BCVA)
Measured as the ETDRS letter score on the EVA tester or E-ETDRS charts.
Measured: 24 Weeks (Changes from baseline)
Intraocular pressure (IOP)
IOP measurement by applanation or rebound tonometry.
Measured: 24 weeks(Changes from baseline)
Color fundus photography
Color fundus photographs will be taken to evaluate retinal anatomy and grade diabetic retinopathy severity scale (DRSS).
Measured: 24 Weeks(Changes from baseline)
Spectral Domain Optical Coherence Tomography (SD-OCT)
SD-OCT will be utilized to assess retinal thickness. OCT images and scans will be transmitted to a central reading center for independent analysis.
Measured: 24 Weeks(Changes from baseline)
Spectral Domain Optical Coherence Tomography Angiography (SD-OCTA)
SD-OCTA will be utilized to assess retinal vasculature and images will be transmitted to a central reader for independent analysis.
Measured: 24 weeks (Changes from baseline)
Wide-field Fluorescein Angiography (wf-FA)
wf-FA will be conducted at screening and EOS visits to assess central and peripheral vasculature.
Measured: 24 weeks (Changes from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start13 Jan 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Center Involved Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 design with parallel and sequential dosing.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ocugen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Henrick, RN, MS, Study director, OcugenMohamed Genead, MD, Study chair, Ocugen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802329
- Sponsor's protocol ID
- OCU200-101
- Acronym
- DME
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05802329
- Acronym / sponsor ID
- DME / OCU200-101
- Keywords
- anti-VEGF, Transferrin, Tumstatin, DME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- OcugenIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
Detailed description
This is a multicenter, open-label, dose ranging study with 4 cohorts in the dose-escalation portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used.
Under the escalation design, 12 subjects will be enrolled if there are no DLTs and up to 24 subjects under the condition that exactly 1 of the 3 subjects of every cohort if determined to have a DLT.
Each subject will receive a total of 2 intravitreal injections of OCU200 6 weeks apart.
The DSMB will review the sentinel subject 1 week safety data post dosing in every cohort of all 3 subjects.
Cohort 1: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 2: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 3: 3+3 participants will receive intravitreal injection of OCU200.
Cohort 4: 3+3 participants will receive intravitreal injection of OCU200.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3+3 design with parallel and sequential dosing.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: OCU2003+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration). |
| Cohort 2 | Experimental | Drug: OCU2003+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration). |
| Cohort 3 | Experimental | Drug: OCU2003+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration). |
| Cohort 4 | Experimental | Drug: OCU2003+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Decreased visual acuity attributable primarily to DME
- Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:
- BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
- Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
Key exclusion criteria (11 listed)
- Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
- Uncontrolled hypertension
- Uncontrolled glaucoma
- Concurrent disease in the study eye, other than central-involved DME
- Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCU200Intravitreal Injection | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Study Drug-related adverse events (SDAE)
Time frame: 24 weeks
Counts, frequencies and percentages of SDAEs.
Treatment-emergent adverse events (TEAEs)
Time frame: 24 weeks
Counts, frequencies and percentages TEAEs.
Serious adverse events (SAEs)
Time frame: 24 weeks
Counts, frequencies and percentages of SAEs.
6 secondary outcomes
Best-corrected visual acuity (BCVA)
Time frame: 24 Weeks (Changes from baseline)
Intraocular pressure (IOP)
Time frame: 24 weeks(Changes from baseline)
Color fundus photography
Time frame: 24 Weeks(Changes from baseline)
Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: 24 Weeks(Changes from baseline)
Spectral Domain Optical Coherence Tomography Angiography (SD-OCTA)
Time frame: 24 weeks (Changes from baseline)
Wide-field Fluorescein Angiography (wf-FA)
Time frame: 24 weeks (Changes from baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oscar Cuzzani, MD, PhD contact
Jennifer Henrick, RN, MS study director
Ocugen
Mohamed Genead, MD study chair
Ocugen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OCU200 in people with Center Involved Diabetic Macular Edema and Diabetic Macular Edema, run by Ocugen at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roshan A George, MD, MPH (845-664-1505, roshan.george@ocugen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Drug-related adverse events (SDAE) (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.