Status:
RECRUITING
A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema
Lead Sponsor:
Incepta Pharmaceuticals Ltd
Collaborating Sponsors:
Institute for Developing Science and Health Initiatives, Bangladesh
Conditions:
Diabetic Macular Edema
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Macular edema in diabetes, defined as retinal thickening within two disc diameters of the center of the macula, results from retinal microvascular changes that compromise the blood-retinal barrier, ca...
Detailed Description
This is a randomized, double-blind, parallel study that will be conducted in patients with Diabetic Macular Edema (DME) to assess efficacy and safety between test and reference products. Total 70 subj...
Eligibility Criteria
Inclusion Criteria:
- Ages Eligible for Study: ≥ 18 Years
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Diagnosis of diabetes mellitus (type 1 or 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: Laboratory reports that prove DM of patient or current regular use of insulin for treatment of diabetes or current regular use of oral anti-hyperglycemic agent for the treatment of diabetes.
- Clinical evidence of retinal thickening due to macular edema involving the center of the macula (can be associated with diabetic retinopathy)
- Central diabetic macular edema present on clinical examination and OCT testing with central 1mm sub field thickness greater than 300 microns as measured on -OCT
- Visual acuity score greater than or equal to 19 letters (20/400) and less than or equal to 73 letters (20/40) by the ETDRS/ Snellen chart visual acuity protocol
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
- Willingness and ability to undertake all scheduled visits and assessments
Exclusion Criteria:
- Prior treatment with any Intravitreal drug, Bevacizumab, verteporfin or photodynamic therapy (except for extra foveal laser photocoagulation) in the study eye within past 3 months before study entry
- Laser photocoagulation in the study eye within 1 month before study entry
- Participation in another ocular investigation or trial simultaneously
- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
- Blood pressure > 160/100 mmHg (systolic above 160 or diastolic above 100) and Random Blood Sugar (RBS) ≥ 12 mmol/L and/ or HbA1c ≥ 7.5%
- Evidence of vitreoretinal interface abnormality and optic nerve disease after ocular exam or OCT that may be contributing to the macular edema
- Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period or that could contribute to a loss of best corrected visual acuity over the study period (e.g. cataract that might decrease the vision by 3 or more lines, uncontrolled glaucoma, uveitis, previous corneal transplant etc.). The decision regarding exclusion is to be based on the opinion of the investigator.
- An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of sub retinal fibrosis or geographic atrophy).
- Presence of suspected ocular or periocular infections, another ocular condition that may affect the visual acuity or macular edema during the course of the study (uveitis, Irvine-Gas)
- Vitreous hemorrhage preventing visualization of retina
- History of vitreous surgery, cataract surgery, YAG capsulotomy in the study eye within last 3 months of enrolment
- Visual acuity <20/400 in the fellow eye
- Known hypersensitivity to Ranibizumab or any of the components of study medication
- History of cerebral vascular accident or myocardial infarction within past 3 months.
- Employees of Investigational sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
- Current use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/ hydroxychloroquine, tamoxifen, phenothiazine, vigabatrin and ethambutol, and such medications will not be allowed during the study period.
Key Trial Info
Start Date :
March 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06305416
Start Date
March 30 2024
End Date
December 1 2025
Last Update
June 6 2025
Active Locations (1)
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1
Bangladesh Eye Hospital & Institute
Dhaka, Bangladesh, 1209