Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

A Real-world, Prospective, Multi-center, Open-label, Phase IV Clinical Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)

ClinicalTrials.gov Identifier: NCT05269966

Novartis Reference Number: CRTH258AIN01

Last Update: May 13, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) 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.

Condition 
Neovascular Age-related Macular Degeneration (nAMD)
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Mar 10, 2022
Completion date 
Feb 01, 2024
Gender 
All
Age(s)
18 Years - 100 Years (Adult, Older Adult)

Interventions

Biological
Injection Brolucizumab
Single-chain antibody fragment (scFv) Brolucizumab 6 mg will be administered by IVT injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients will receive loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) will be performed based on BCVA and OCT to assess whether the patient will require q8w or q12w dosing.

Eligibility Criteria

Inclusion Criteria:

Female or male, treatment naïve patient with ≥50 years of age, with neovascular age-related macular degeneration (nAMD).
Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.

Note: In case where both eyes are affected, data of only one eye ['study eye'] will be recorded. Selection of the eye to be considered for the purpose of the study [referred to as 'study eye'] will be as per the Investigator's discretion.

Exclusion Criteria:

Patients fulfilling any of the following criteria are not eligible for this study:
Patient having other eye diseases that could compromise the VA.
Patient with existing or suspected ocular or periocular infection in the study eye.
Patient with an existing intraocular inflammation (IOI).
Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment.
Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study.
Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.

Study Locations

India
Novartis Investigative Site
Recruiting
Ahmedabad, 380052
Gujarat
India
Novartis Investigative Site
Recruiting
Bangalore, 560 010
Karnataka
India
Novartis Investigative Site
Recruiting
Chennai, 600018
Tamilnadu
India
Novartis Investigative Site
Recruiting
Hyderabad,
Telangana
India
Novartis Investigative Site
Recruiting
Varanasi, 221010
Uttar Pradesh
India
Novartis Investigative Site
Recruiting
Kolkatta, 700 073
West Bengal
India
Novartis Investigative Site
Recruiting
Hooghly,
-
India
Novartis Investigative Site
Recruiting
New Delhi, 110029
-
India

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]