Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305416
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-03-05
Brief Title:
A Efficacy and Safety Study of Ranibizumab 10mgml Injection Incepta in Patients With Diabetic Macular Edema
Sponsor:
Incepta Pharmaceuticals Ltd
Organization:
Incepta Pharmaceuticals Ltd
Study Overview
Official Title:
Randomized Double-blind Parallel Active Controlled Study to Compare Efficacy Safety Between Ranibizumab 10mgml Injection of Incepta and Lucentis in Patients With Diabetic Macular Edema by ITV Injection
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 This compromise of the blood-retinal barrier leads to the leakage of plasma constituents into the surrounding retina with subsequent retinal edema Hypoxia produced by this mechanism can also stimulate the production of vascular endothelial growth factor VEGF Vascular endothelial growth factor VEGF increases retinal vascular permeability causes breakdown of the blood-retina barrier and results in retinal edema
Diabetic macular edema DME is the most common cause of visual reduction in patients with Diabetes Mellitus The prevalence of DME globally is around 68 Diabetic Retinopathy DR is the most common microvascular complication of diabetes and the leading cause of blindness worldwide DME is a complication of diabetic retinopathy that affects the macula which is located at the center of the retina and responsible for central vision Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 71 million 53-120 In Bangladesh it is therefore expected that diabetic secondary complications like DR will increase along with the rising trend of diabetes mellitus
The use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases In recent years millions of patients have been successfully treated with these biological agents Ranibizumab is one such therapeutic monoclonal antibody for intraocular use Ranibizumab is a humanized recombinant immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A VEGF-A and thus prevents choroidal neovascularization The small size of ranibizumab allows for enhanced diffusion into the retina and choroid
Diabetic macular edema DME is the most common cause of visual reduction in patients with Diabetes Mellitus The prevalence of DME globally is around 68 Diabetic Retinopathy DR is the most common microvascular complication of diabetes and the leading cause of blindness worldwide DME is a complication of diabetic retinopathy that affects the macula which is located at the center of the retina and responsible for central vision Bangladesh is the 10th country in the world for the number of adults living with diabetes with some 71 million 53-120 In Bangladesh it is therefore expected that diabetic secondary complications like DR will increase along with the rising trend of diabetes mellitus
The use of therapeutic monoclonal antibodies has revolutionized in the treatment of many diseases In recent years millions of patients have been successfully treated with these biological agents Ranibizumab is one such therapeutic monoclonal antibody for intraocular use Ranibizumab is a humanized recombinant immunoglobulin G1 monoclonal antibody fragment against vascular endothelial growth factor A VEGF-A and thus prevents choroidal neovascularization The small size of ranibizumab allows for enhanced diffusion into the retina and choroid
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 subjects with DME are planned to be randomized into this study
Enrolled subjects will receive total 3 doses of 05 mg Intravitreal injection of either test or reference product once every 4 Weeks Day 0 Week 43 days and Week 83 days All subjects will have their first injection of ranibizumab on Day 0 and undergo a safety visit 48hrs after the first injection At subsequent visits the subject will have a safety follow up prior to each intravitreal injection Also the subject will have a safety follow up visit 48hrs after second and third injection The final visit or end of study visit will be on Week 123 days for efficacy and safety evaluation
Enrolled subjects will receive total 3 doses of 05 mg Intravitreal injection of either test or reference product once every 4 Weeks Day 0 Week 43 days and Week 83 days All subjects will have their first injection of ranibizumab on Day 0 and undergo a safety visit 48hrs after the first injection At subsequent visits the subject will have a safety follow up prior to each intravitreal injection Also the subject will have a safety follow up visit 48hrs after second and third injection The final visit or end of study visit will be on Week 123 days for efficacy and safety evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None