A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema

NCT06305416 | Recruiting Phase 3 DMC

• 1 other identifier: 2023/CT/01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 6.8 %. 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 7.1 million (5.3-12.0). 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.

Conditions

Diabetic Macular Edema; Diabetic Retinopathy; Macular Edema; Macular Degeneration; Retinal Disease; Retinal Degeneration

Keywords

Ranibizumab; Efficacy; Diabetes; Retina; Edema

Outcome Measures

Primary Outcomes (2)

• Changes in Best Corrected Visual Acuity (BCVA) from Baseline

  To determine the changes in the BCVA was assessed using ETDRS charts or Snellen charts from baseline to Week 12

  Baseline and Week 12

• Changes in Central Subfield Thickness (CST) from Baseline

  To determine the changes in central 1mm subfield thickness as measured by OCT and FA from baseline to week 12

  Baseline and Week 12

Secondary Outcomes (3)

• Proportion of patients who lost fewer than 15 letters (approximately 3 lines) from baseline visual acuity

  Baseline and Week 12

• Proportion of patients who gained ≥15 letters (approximately 3 lines) from baseline visual acuity

  Baseline and Week 12

• Evaluation and comparison of safety between reference vs. test drug.

  Baseline and upto Week 12

Study Arms (2)

Ranibizumab 10mg/ml Injection (Proposed Ranibizumab Biosimilar)

EXPERIMENTAL

Test Group of 35 adult patient with DME will get Ranibizumab (Proposed Ranibizumab Biosimilar)

Drug: Ranibizumab 10mg/ml Injection

Lucentis (Ranibizumab)

ACTIVE COMPARATOR

Comparator Group of 35 adult patient with DME will get Lucentis

Drug: Lucentis

Interventions

Ranibizumab 10mg/ml Injection DRUG

Ranibizumab 10mg/ml Injection (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks

Also known as: Test Product

Ranibizumab 10mg/ml Injection (Proposed Ranibizumab Biosimilar)

Lucentis DRUG

Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks

Also known as: Reference Product

Lucentis (Ranibizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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: 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Incepta Pharmaceuticals Ltd: lead
• Institute for Developing Science and Health Initiatives, Bangladesh: collaborator

Study Sites (1)

Bangladesh Eye Hospital & Institute

Dhaka, 1209, Bangladesh

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy; Macular Edema; Macular Degeneration; Retinal Diseases; Retinal Degeneration; Diabetes Mellitus; Edema

Interventions

Ranibizumab; Injections

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Eye Diseases, Hereditary; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dr. Niaz Abdur Rahman

  Managing Director, Bangladesh Eye Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faez Ahmed

CONTACT

+880-2-8891688-703; faez@inceptapharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: March 30, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After completion of study
• Access Criteria: Journal

Locations

BA (1)