Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.

NCT05959304 | Completed Phase 4

• 1 other identifier: CRTH258BIN01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 8

Brief 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. This study is being conducted as part of the post-marketing regulatory commitment to the Indian Health authority.

Conditions

Diabetic Macular Edema

Keywords

Vision Loss; Macular Edema; Metamorphopsia

Outcome Measures

Primary Outcomes (1)

• 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).

  40 weeks

Secondary Outcomes (6)

• Mean change in BCVA from Baseline to Week 40 as measured by ETDRS letters.

  Baseline, week 40

• Percentage of patients with presence/absence of IRF and SRF at Week 40 compared to Baseline.

  Baseline, week 40

• Mean change in CRT as assessed by Optical Coherence Tomography (OCT) from Baseline to Week 40.

  Baseline, week 40

• Number of brolucizumab injections administered to the patients during 40 weeks of treatment with brolucizumab.

  40 weeks

• Number of non-injection visits during 40 weeks of treatment with brolucizumab.

  40 weeks

Study Arms (1)

brolucizumab 6 mg

EXPERIMENTAL

brolucizumab 6 mg intravitreal injection

Drug: brolucizumab

Interventions

brolucizumab DRUG

There is no treatment allocation. Treatment with brolucizumab 6 mg intravitreal injection will be based on the local label/clinical practice.

brolucizumab 6 mg

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Ahmedabad, Gujarat, 380052, India

Location

Novartis Investigative Site

Bangalore, Karnataka, 560 010, India

Location

Novartis Investigative Site

Kochi, Kerala, 682 026, India

Location

Novartis Investigative Site

Chennai, Tamil Nadu, 600045, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700 073, India

Location

Novartis Investigative Site

Coimbatore, 641002, India

Location

Novartis Investigative Site

Kolkata, 700120, India

Location

Novartis Investigative Site

New Delhi, 110029, India

Location

MeSH Terms

Conditions

Vision Disorders; Macular Edema

Interventions

brolucizumab

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: December 11, 2024
• Primary Completion: November 17, 2025
• Study Completion: November 17, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (8)