Clinical trial NCT05959304: Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
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).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Macular Edema
Keywords: Vision Loss
Macular Edema
Metamorphopsia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of adult male and female patients aged 18 years and above, diagnosed with DME for whom the Investigator prescribes treatment with brolucizumab 6 mg injection in adherence to local Prescribing Information (PI).

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients ≥ 18 years old with visual impairment due to DME involving the center of the macula.
2. Patients with type 1 or type 2 diabetes mellitus.
3. Patient or legally acceptable representative (LAR) must provide signed informed consent for participation in the study.

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Exclusion Criteria:

1. 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).
2. Patient with existing or suspected ocular or periocular infection in the study eye.
3. Patient with an existing intraocular inflammation (IOI) in the study eye.
4. Patient who has undergone intraocular surgery including laser photocoagulation in the study eye within 3 months prior to enrollment in this study.
5. Patient with uncontrolled glaucoma defined as intraocular pressure \> 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
6. Patient having scar, fibrosis, and atrophy involving the center of the fovea in the study eye.
7. Active proliferative diabetic retinopathy in the study eye as per Investigator.
8. Patient having history of cardiac or cerebral ischemia in last 6 months prior to enrollment in this study.
9. Previous treatment with any anti-VEGF drugs, steroids (dexamethasone intravitreal implant or triamcinolone acetonide) or other investigational drugs in the study eye.
10. 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.

Primary outcomes:
measure: Incidence and characteristics of treatment-emergent adverse events during the 40 weeks of treatment with Brolucizumab.
timeFrame: 40 weeks
Secondary outcomes:
measure: Mean change in BCVA from Baseline to Week 40 as measured by ETDRS letters.
timeFrame: Baseline, week 40
measure: Percentage of patients with presence/absence of IRF and SRF at Week 40 compared to Baseline.
timeFrame: Baseline, week 40
measure: Mean change in CRT as assessed by Optical Coherence Tomography (OCT) from Baseline to Week 40.
timeFrame: Baseline, week 40
measure: Number of brolucizumab injections administered to the patients during 40 weeks of treatment with brolucizumab.
timeFrame: 40 weeks
measure: Number of non-injection visits during 40 weeks of treatment with brolucizumab.
timeFrame: 40 weeks
measure: Total number of visits during 40 weeks of treatment with brolucizumab.
timeFrame: 40 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: