Diabetic Macular EdemaPhase 3NCT06305416
A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema
A Phase 3 study testing Ranibizumab 10mg/ml Injection and Lucentis in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Incepta Pharmaceuticals Ltd at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema
- What is being tested?
- Ranibizumab 10mg/ml Injection and Lucentis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBangladesh
- Study dates
- 30 Mar 2024to 17 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Parallel, Active Controlled Study to Compare Efficacy & Safety Between Ranibizumab 10mg/ml Injection of Incepta and Lucentis in Patients With Diabetic Macular Edema by ITV Injection
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.
Read the 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 0.5 mg Intravitreal injection of either test or reference product once every 4 Weeks (Day 0, Week 4±3 days and Week 8±3 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 12±3 days for efficacy and safety evaluation.
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema, Macular Degeneration, Retinal Disease, Retinal Degeneration
- Being tested
- Ranibizumab 10mg/ml Injection, Lucentis
- Keywords
- Ranibizumab, Efficacy, Diabetes, Retina, Edema
- Medical subject headings
- Diabetic Retinopathy, Macular Edema, Macular Degeneration, Retinal Diseases, Retinal Degeneration, Diabetes Mellitus, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 10mg/ml InjectionDrug
Also called Test Product
Ranibizumab 10mg/ml Injection (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
LucentisDrug
Also called Reference Product
Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 10mg/ml Injection (Proposed Ranibizumab Biosimilar) | Experimental | Test Group of 35 adult patient with DME will get Ranibizumab (Proposed Ranibizumab Biosimilar) Receives: Drug: Ranibizumab 10mg/ml Injection |
| Lucentis (Ranibizumab) | Active comparator | Comparator Group of 35 adult patient with DME will get Lucentis Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and Week 12
Secondary outcomes (3)
Proportion of patients who lost fewer than 15 letters (approximately 3 lines) from baseline visual acuity
The VA will be assessed using ETDRS charts or Snellen charts.
Measured: Baseline and Week 12
Proportion of patients who gained ≥15 letters (approximately 3 lines) from baseline visual acuity
The VA will be assessed using ETDRS charts or Snellen charts.
Measured: Baseline and Week 12
Evaluation and comparison of safety between reference vs. test drug.
Incidence of drug related adverse events as assessed by clinical and ophthalmic examination, vitals and laboratory parameters in both treatment arms
Measured: Baseline and upto Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start30 Mar 2024
- Primary completion10 Mar 2026
- Study completion17 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incepta Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for Developing Science and Health Initiatives, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Dr. Niaz Abdur Rahman, Principal investigator, Managing Director, Bangladesh Eye Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305416
- Sponsor's protocol ID
- 2023/CT/01
- Status last verified
- Sep 2026
- First submitted
- 5 Mar 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By publication in the journal
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel, Active Controlled Study to Compare Efficacy & Safety Between Ranibizumab 10mg/ml Injection of Incepta and Lucentis in Patients With Diabetic Macular Edema by ITV Injection
- ClinicalTrials.gov ID
- NCT06305416
- Acronym / sponsor ID
- 2023/CT/01
- Conditions
- Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema, Macular Degeneration, Retinal Disease, Retinal Degeneration
- Keywords
- Ranibizumab, Efficacy, Diabetes, Retina, Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Incepta Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Collaborators
- Institute for Developing Science and Health Initiatives, Bangladesh
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 17 May 2026 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 0.5 mg Intravitreal injection of either test or reference product once every 4 Weeks (Day 0, Week 4±3 days and Week 8±3 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 12±3 days for efficacy and safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 10mg/ml Injection (Proposed Ranibizumab Biosimilar) | Experimental | Drug: Ranibizumab 10mg/ml InjectionTest Group of 35 adult patient with DME will get Ranibizumab (Proposed Ranibizumab Biosimilar) |
| Lucentis (Ranibizumab) | Active comparator | Drug: LucentisComparator Group of 35 adult patient with DME will get Lucentis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ranibizumab 10mg/ml InjectionAlso: Test ProductRanibizumab 10mg/ml Injection (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks | Drug | Ranibizumab 10mg/ml Injection (Proposed Ranibizumab Biosimilar) |
| LucentisAlso: Reference ProductLucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks | Drug | Lucentis (Ranibizumab) |
Primary outcome
Changes in Best Corrected Visual Acuity (BCVA) from Baseline
Time frame: Baseline and Week 12
To determine the changes in the BCVA was assessed using ETDRS charts or Snellen charts from baseline to Week 12
Changes in Central Subfield Thickness (CST) from Baseline
Time frame: Baseline and Week 12
To determine the changes in central 1mm subfield thickness as measured by OCT and FA from baseline to week 12
3 secondary outcomes
Proportion of patients who lost fewer than 15 letters (approximately 3 lines) from baseline visual acuity
Time frame: Baseline and Week 12
Proportion of patients who gained ≥15 letters (approximately 3 lines) from baseline visual acuity
Time frame: Baseline and Week 12
Evaluation and comparison of safety between reference vs. test drug.
Time frame: Baseline and upto Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. By publication in the journal
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Niaz Abdur Rahman principal investigator
Managing Director, Bangladesh Eye Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ranibizumab 10mg/ml Injection and Lucentis in people with Diabetic Macular Edema and Diabetic Retinopathy, run by Incepta Pharmaceuticals Ltd at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Best Corrected Visual Acuity (BCVA) from Baseline (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.