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Tests treatment safety and results for Diabetic Macular Edema
Official title A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema
ClinicalTrials.gov ID: NCT06305416
What this study is testing
What is Ranibizumab 10mg/ml Injection?
Ranibizumab 10mg/ml Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for diabetic macular edema.
Also referred to as Test Product.
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
- 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, causing leakage of plasma constituents into the surrounding retina and consequently retinal edema. Thickening of the basement membrane and reduction in the number of pericytes are believed to lead to increased permeability and incompetence of the retinal vasculature.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
You may be able to join if
- 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...
- 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...
You likely can't join if
- Prior treatment with any Intravitreal drug, Bevacizumab, verteporfin or photodynamic therapy (except for extra foveal laser photocoagulation) in the...
- 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
See the full eligibility 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Bangladesh
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Bangladesh. 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.