Actively Recruiting
Randomized, Double-blind Study Comparing Ranibizumab 10mg/ml Injection (Incepta) and Lucentis in Patients With Diabetic Macular Edema via Intravitreal Injection
Led by Incepta Pharmaceuticals Ltd · Updated on 2025-06-06
70
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
I
Incepta Pharmaceuticals Ltd
Lead Sponsor
I
Institute for Developing Science and Health Initiatives, Bangladesh
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diabetic Macular Edema (DME) is a complication of diabetes that causes swelling in the central part of the retina, leading to vision loss. This condition results from changes in the small blood vessels of the retina, causing leakage and retinal thickening, often linked to increased levels of vascular endothelial growth factor (VEGF). DME is a common cause of blindness in people with diabetes, and it is especially significant in Bangladesh due to the high number of adults living with diabetes. This study compares the effectiveness and safety of two treatments for DME: a proposed biosimilar of Ranibizumab and Lucentis, both given as 0.5 mg injections into the eye every four weeks. A total of 70 adults with DME will be randomly assigned to receive one of these treatments in three doses over eight weeks. Safety visits will occur 48 hours after each injection, and the study concludes with an evaluation visit at week 12. Participants will undergo vision tests and imaging of the retina at the start and end of the study to measure changes in visual acuity and retinal thickness. Safety will be monitored throughout with follow-up visits shortly after each injection. Researchers will track how many patients maintain or improve their vision and assess any side effects. The total participation time for each patient is approximately 12 weeks.
CONDITIONS
Brief Title
A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to provide written informed consent and comply with study assessments
- Diagnosis of diabetes mellitus (type 1 or 2) confirmed by lab reports or current diabetes medication
- Clinical evidence of retinal thickening due to macular edema involving the center of the macula
- Central macular thickness greater than 300 microns on OCT testing
- Visual acuity between 19 letters (20/400) and 73 letters (20/40) on ETDRS or Snellen chart
- Media clarity, pupil dilation, and cooperation sufficient for OCT and retinal photography
- Willingness and ability to attend all scheduled visits and assessments
You will not qualify if you...
- Prior intravitreal drug treatment or photodynamic therapy in the study eye within 3 months (except extra foveal laser)
- Laser photocoagulation in the study eye within 1 month before study entry
- Participation in another ocular trial simultaneously
- Pregnancy or pre-menopausal women not using adequate contraception
- Blood pressure over 160/100 mmHg, random blood sugar ≥ 12 mmol/L, or HbA1c ≥ 7.5%
- Vitreoretinal interface abnormality or optic nerve disease affecting macular edema
- Other intraocular conditions in the study eye requiring treatment or causing vision loss
- Eye with no chance of visual improvement due to fibrosis or atrophy
- Suspected ocular infections or conditions affecting vision during the study
- Vitreous hemorrhage preventing retina visualization
- Recent vitreous, cataract surgery or YAG capsulotomy within 3 months
- Visual acuity less than 20/400 in the other eye
- Known hypersensitivity to Ranibizumab or its components
- Recent stroke or heart attack within 3 months
- Employees or immediate family of study site staff, prisoners, or legally institutionalized persons
- Current use of systemic medications toxic to lens, retina, or optic nerve not allowed during study period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive 3 doses of intravitreal injection of either Ranibizumab 10mg/ml or Lucentis once every 4 weeks. Safety follow-up visits occur 48 hours after each injection and prior to subsequent injections.
3 injection visits and 4 safety follow-up visits (including 48-hour post-injection visits and pre-injection safety assessments)
Duration - At Week 12
Participants attend a final visit for efficacy and safety evaluation at the end of the treatment period.
1 final visit (in-person)
Trial Site Locations
Total: 1 location
1
Bangladesh Eye Hospital & Institute
Dhaka, Bangladesh, 1209
Actively Recruiting
Research Team
F
Faez Ahmed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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