To evaluate the safety and effectiveness of intravitreal injections of brolucizumab in patients with neovascular age-related macular degeneration
- Conditions
- Other specified disorders of eye and adnexa,
- Registration Number
- CTRI/2022/01/039718
- Lead Sponsor
- Novartis Healthcare Private Limited
- Brief Summary
Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people affecting 10%-13% of individuals over the age of 65 in North America, Europe, and Australia . Genetic, environmental, and health factors play an important role in the pathogenesis of the disease.
The purpose of this study is to generate additional safety and effectiveness data in a larger nAMD patient population in India that more closely resembles the real-world population intended to be treated with brolucizumab.
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 105
- 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.
- Patient having other eye diseases that could compromise the visual acuity (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 & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and characteristics of treatment-emergent adverse events baseline to Week 56.
- Secondary Outcome Measures
Name Time Method To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA) baseline to Week 56. Characterize the number of anti-VEGF injections, number of non-injection visits, and total number of visits baseline to Week 56. Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w baseline to Week 56. Estimate effect of brolucizumab on fluid baseline to week 16 and week 56. Estimate effect of brolucizumab on central subfield thickness (CST) baseline to week 16 and week 56.
Trial Locations
- Locations (11)
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
🇮🇳Delhi, DELHI, India
Disha Eye Hospitals Pvt. Ltd.
🇮🇳Hugli, WEST BENGAL, India
Dr. Agarwal s Eye Hospital Ltd
🇮🇳Chennai, TAMIL NADU, India
Government Eye Hospital
🇮🇳Ahmadabad, GUJARAT, India
L V Prasad Eye Institute
🇮🇳Hyderabad, TELANGANA, India
Narayana Nethralaya
🇮🇳Bangalore, KARNATAKA, India
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, CHANDIGARH, India
R.K.Netralaya Eye Hospital Pvt. Ltd
🇮🇳Varanasi, UTTAR PRADESH, India
Raghudeep Eye Hospital
🇮🇳Ahmadabad, GUJARAT, India
Regional Institute of Ophthalmology
🇮🇳Kolkata, WEST BENGAL, India
Scroll for more (1 remaining)ALL INDIA INSTITUTE OF MEDICAL SCIENCES🇮🇳Delhi, DELHI, IndiaDr Rohan ChawlaPrincipal investigator011-26588500dr.rohanrpc@gmail.com