Actively Recruiting
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
Led by RemeGen Co., Ltd. · Updated on 2023-09-05
316
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
CONDITIONS
Official Title
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type I or type II diabetes mellitus.
- Hemoglobin A1c (HBA1c) less than or equal to 10% within 2 months before study start.
- Ability and willingness to attend all scheduled visits and assessments.
- Study eye has macular thickening due to diabetic macular edema involving the center of the fovea.
- Best corrected visual acuity (BCVA) in the study eye between 19 and 78 letters.
You will not qualify if you...
- Study eye has high risk of proliferative diabetic retinopathy.
- Macular edema in the study eye caused mainly by conditions other than diabetic macular edema.
- Panretinal photocoagulation or macular laser treatment in the study eye within 3 months before study start.
- Anti-VEGF injections in the study eye within 3 months or in the other eye within 7 days before study start.
- Long-acting corticosteroid treatment in the study eye within 6 months before study start.
- Active intraocular or periocular infection or inflammation in either eye.
- Poorly controlled glaucoma in the study eye.
- History of idiopathic or autoimmune uveitis in either eye.
- Stroke or heart attack within 6 months before study start.
- Uncontrolled blood pressure above 180/100 mmHg at rest.
- Currently pregnant, breastfeeding, or planning pregnancy during the study.
- Any other eye diseases that could affect vision or assessment in the study eye.
- Other protocol-specified criteria may apply.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
Research Team
B
Binghua Xiao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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