Diabetic Macular EdemaPhase 4NCT05959304
Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
A Phase 4 study testing brolucizumab in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 8 sites in India.
Trial summary
The purpose of this study is to generate additional safety and effectiveness data in Indian Diabetic macular edema (DME) patients that more closely resemble the real-world population intended to be treated with Brolucizumab. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- brolucizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 8 sitesIndia
- Study dates
- 11 Dec 2024to 17 Nov 2025
- Phase
- Phase 4
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 18 years old with visual impairment due to DME involving the center of the macula.
- Patients with type 1 or type 2 diabetes mellitus.
- Patient or legally acceptable representative (LAR) must provide signed informed consent for participation in the study.
- -
Who cannot join
- Concomitant conditions or ocular disorders in the study eye at screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause).
- Patient with existing or suspected ocular or periocular infection in the study eye.
- Patient with an existing intraocular inflammation (IOI) in the study eye.
- Patient who has undergone intraocular surgery including laser photocoagulation in the study eye within 3 months prior to enrollment in this study.
- Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
- Patient having scar, fibrosis, and atrophy involving the center of the fovea in the study eye.
Show all 10Show fewer
- Active proliferative diabetic retinopathy in the study eye as per Investigator.
- Patient having history of cardiac or cerebral ischemia in last 6 months prior to enrollment in this study.
- Previous treatment with any anti-VEGF drugs, steroids (dexamethasone intravitreal implant or triamcinolone acetonide) or other investigational drugs in the study eye.
- Pregnant or nursing (lactating) women at screening, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG pregnancy test.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380052
Novartis Investigative Site
Bangalore, Karnataka, 560 010
Novartis Investigative Site
Chennai, Tamil Nadu, 600045
Novartis Investigative Site
Coimbatore, 641002
Novartis Investigative Site
Kochi, Kerala, 682 026
Novartis Investigative Site
Kolkata, West Bengal, 700 073
Novartis Investigative Site
Kolkata, 700120
Novartis Investigative Site
New Delhi, 110029
About this study
Official title: A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Diabetic Macular Edema (DME).
The purpose of this study is to generate additional safety and effectiveness data in Indian Diabetic macular edema (DME) patients that more closely resemble the real-world population intended to be treated with Brolucizumab. This study is being conducted as part of the post-marketing regulatory commitment to the Indian Health authority.
Read the detailed description
This study is a prospective, non-interventional, open-label, single-arm, multi-center phase IV study to evaluate safety and effectiveness of intravitreal injections (IVI) of brolucizumab in patients with diabetic macular edema (DME) for whom a decision has already been made to be treated with brolucizumab, irrespective of the trial participation. The study period for each patient will be 40 weeks from the informed consent and enrolment in the study.
Assessments/investigations shall be performed in accordance to the local clinical practice and the Investigator's assessed response will be collected in the database. Any patient who suffers from intraocular inflammation (IOI) during the study, treatment with brolucizumab will be discontinued.
Data originating from assessments and evaluations performed at routine patient visits will be collected from the patient's medical records at Baseline, i.e., the start of brolucizumab treatment, and approximately at Week 6, Week 12, Week 18, Week 24, Week 32, Week 36, and at Week 40. Safety data (AEs and SAEs) from any time point during the duration of the study.
- Conditions
- Diabetic Macular Edema
- Being tested
- brolucizumab
- Keywords
- Vision Loss, Macular Edema, Metamorphopsia
- Medical subject headings
- Vision Disorders, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brolucizumabDrug
There is no treatment allocation. Treatment with brolucizumab 6 mg intravitreal injection will be based on the local label/clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| brolucizumab 6 mg | Experimental | brolucizumab 6 mg intravitreal injection Receives: Drug: brolucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and characteristics of treatment-emergent adverse events during the 40 weeks of treatment with Brolucizumab.
To evaluate ocular \& non-ocular safety of intravitreal brolucizumab in real-world patients with Diabetic Macular Edema (DME).
Measured: 40 weeks
Secondary outcomes (6)
Mean change in BCVA from Baseline to Week 40 as measured by ETDRS letters.
To evaluate the effectiveness of brolucizumab in the management of DME in terms of change in best-corrected visual acuity (BCVA) from Baseline to Week 40 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters.
Min and max possible scores are 0-100 letters read respectively. A higher score represents better visual functioning.
Measured: Baseline, week 40
Percentage of patients with presence/absence of IRF and SRF at Week 40 compared to Baseline.
To evaluate the effectiveness of brolucizumab on fluid [intraretinal fluid (IRF) and subretinal fluid (SRF)] from Baseline to Week 40.
Measured: Baseline, week 40
Mean change in CRT as assessed by Optical Coherence Tomography (OCT) from Baseline to Week 40.
To evaluate the effectiveness of brolucizumab on central retinal thickness (CRT) from Baseline to Week 40.
Measured: Baseline, week 40
Number of brolucizumab injections administered to the patients during 40 weeks of treatment with brolucizumab.
To characterize the number of anti-VEGF injections during the 40 weeks of treatment with brolucizumab in the study.
Measured: 40 weeks
Number of non-injection visits during 40 weeks of treatment with brolucizumab.
To characterize the number of non-injection visits during the 40 weeks of treatment with brolucizumab in the study.
Measured: 40 weeks
Total number of visits during 40 weeks of treatment with brolucizumab.
To characterize the total number of visits during the 40 weeks of treatment with brolucizumab in the study.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start11 Dec 2024
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
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.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959304
- Sponsor's protocol ID
- CRTH258BIN01
- Status last verified
- Apr 2026
- First submitted
- 17 Jul 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Diabetic Macular Edema (DME).
- ClinicalTrials.gov ID
- NCT05959304
- Acronym / sponsor ID
- CRTH258BIN01
- Conditions
- Diabetic Macular Edema
- Keywords
- Vision Loss, Macular Edema, Metamorphopsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 25 Jul 2023 (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.
The purpose of this study is to generate additional safety and effectiveness data in Indian Diabetic macular edema (DME) patients that more closely resemble the real-world population intended to be treated with Brolucizumab. This study is being conducted as part of the post-marketing regulatory commitment to the Indian Health authority.
Detailed description
This study is a prospective, non-interventional, open-label, single-arm, multi-center phase IV study to evaluate safety and effectiveness of intravitreal injections (IVI) of brolucizumab in patients with diabetic macular edema (DME) for whom a decision has already been made to be treated with brolucizumab, irrespective of the trial participation. The study period for each patient will be 40 weeks from the informed consent and enrolment in the study.
Assessments/investigations shall be performed in accordance to the local clinical practice and the Investigator's assessed response will be collected in the database. Any patient who suffers from intraocular inflammation (IOI) during the study, treatment with brolucizumab will be discontinued.
Data originating from assessments and evaluations performed at routine patient visits will be collected from the patient's medical records at Baseline, i.e., the start of brolucizumab treatment, and approximately at Week 6, Week 12, Week 18, Week 24, Week 32, Week 36, and at Week 40. Safety data (AEs and SAEs) from any time point during the duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brolucizumab 6 mg | Experimental | Drug: brolucizumabbrolucizumab 6 mg intravitreal injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ≥ 18 years old with visual impairment due to DME involving the center of the macula.
- Patients with type 1 or type 2 diabetes mellitus.
- Patient or legally acceptable representative (LAR) must provide signed informed consent for participation in the study.
- -
Key exclusion criteria (10 listed)
- Concomitant conditions or ocular disorders in the study eye at screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause).
- Patient with existing or suspected ocular or periocular infection in the study eye.
- Patient with an existing intraocular inflammation (IOI) in the study eye.
- Patient who has undergone intraocular surgery including laser photocoagulation in the study eye within 3 months prior to enrollment in this study.
- Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
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 |
|---|---|---|
| brolucizumabThere is no treatment allocation. Treatment with brolucizumab 6 mg intravitreal injection will be based on the local label/clinical practice. | Drug | brolucizumab 6 mg |
Primary outcome
Incidence and characteristics of treatment-emergent adverse events during the 40 weeks of treatment with Brolucizumab.
Time frame: 40 weeks
To evaluate ocular \& non-ocular safety of intravitreal brolucizumab in real-world patients with Diabetic Macular Edema (DME).
6 secondary outcomes
Mean change in BCVA from Baseline to Week 40 as measured by ETDRS letters.
Time frame: Baseline, week 40
Percentage of patients with presence/absence of IRF and SRF at Week 40 compared to Baseline.
Time frame: Baseline, week 40
Mean change in CRT as assessed by Optical Coherence Tomography (OCT) from Baseline to Week 40.
Time frame: Baseline, week 40
Number of brolucizumab injections administered to the patients during 40 weeks of treatment with brolucizumab.
Time frame: 40 weeks
Number of non-injection visits during 40 weeks of treatment with brolucizumab.
Time frame: 40 weeks
Total number of visits during 40 weeks of treatment with brolucizumab.
Time frame: 40 weeks
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 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingPhase 2/3
A Study of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
Diabetic Macular Edema (DME)
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2/3
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing brolucizumab in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 8 sites in India.
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 4 inclusion and 10 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence and characteristics of treatment-emergent adverse events during the 40 weeks of treatment with Brolucizumab. (time frame: 40 weeks). 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 13 Apr 2026.