BridgeMD
Tests treatment safety and results for Center Involved Diabetic Macular Edema
Official title Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)
ClinicalTrials.gov ID: NCT05802329
What this study is testing
What is OCU200?
OCU200 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for center involved diabetic macular edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Deerfield Beach, Florida, United States
- Erie, Pennsylvania, United States
- Bellaire, Texas, United States
- Southlake, Texas, United States
- La Crosse, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Deerfield Beach, Florida, United States; Erie, Pennsylvania, United States; Bellaire, Texas, United States; Southlake, Texas, United States; La Crosse, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.