Clinical trial NCT05269966: Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neovascular Age-related Macular Degeneration (nAMD)
Keywords: Macular degeneration
age-related macular degeneration (ARMD)
vision loss
macula damage
retina damage
dry macular degeneration
wet macular degeneration
Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration
AMD
neovascular age-related macular degeneration
nAMD
retinal vein occlusion
RVO
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 105
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was 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 was conducted as part of the post-marketing regulatory commitment to the Indian Health authority.

Detailed description: The study was a prospective, multi-center, open-label, interventional phase IV clinical study.

The study treatment, i.e., brolucizumab was prescribed in terms of the marketing authorization; the assignment of the patient to the therapy was decided within the current practice and the medical indication. It was clearly separated from the decision to include the patient in the study.

All patients with Neovascular Age-related Macular Degeneration (nAMD) who were planned to be treated with brolucizumab and had provided informed consent were enrolled in the study. A total of 12 sites in India were evaluated for the study conduct. This is to note that site #03 was not selected, and site #07 was not initiated, and patients were enrolled in the study only from 10 sites.

The treatment period for each patient was 56 weeks after the start of brolucizumab treatment.

Study visits were scheduled at Week 4, Week 8, Week 16, and thereafter at intervals of 8 weeks or 12 weeks after disease activity assessment at Week 16. If the investigators required more frequent follow-up visits, it was done according to their discretion and clinical judgment. Any patient who suffered from IOI during the study period was not re-challenged with brolucizumab.

The study population consisted of adult male and female outpatients aged 50 years and above, diagnosed with nAMD for whom the treating the physician (Investigator) had prescribed treatment with brolucizumab 6 mg injection in adherence with the local Summary of Product Characteristics (SmPC) or Prescribing Information (PI).

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.

Primary outcomes:
measure: Incidence and Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab.
timeFrame: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
measure: Incidence of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab - Ocular AEs - Preferred Term
timeFrame: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
measure: Characteristics of Treatment-emergent Adverse Events During the 56 Weeks of Treatment With Brolucizumab
timeFrame: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
measure: Incidence of Ocular Adverse Event (AEs) by System Organ Class (SOC) and Preferred Term (PT) During the 56 Weeks of Treatment With Brolucizumab
timeFrame: Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
Secondary outcomes:
measure: Mean Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Study Eye
timeFrame: Baseline, Week 16, Week 56
measure: Change in Best-Corrected Visual Acuity (BCVA) From Baseline at Week 16 and Week 56 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters - Median - Study Eye
timeFrame: Baseline, Week 16, Week 56
measure: Number and Percentage (%) of Participants With Gain in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
timeFrame: Baseline, Week 16 and Week 56
measure: Number and Percentage (%) of Participants With Loss in Best-Corrected Visual Acuity (BCVA) of 15/10/5 ETDRS Letters or More From Baseline at Week 16 and Week 56 - Study Eye
timeFrame: Baseline, Week 16 and Week 56
measure: Number of Anti-VEGF Injections, During the 56 Weeks of Treatment With Brolucizumab - Study Eye
timeFrame: Week 56
measure: Number of Non-injection Visits During the 56 Weeks of Treatment With Brolucizumab
timeFrame: Week 56
measure: Total Number of Visits During the 56 Weeks of Treatment With Brolucizumab.
timeFrame: Week 56
measure: Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 8 Weeks But <12 Weeks.
timeFrame: Week 56
measure: Number and Percentage (%) of Participants With at Least One Duration of Interval Between Injections ≥ 12 Weeks.
timeFrame: Week 56
measure: Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Absent at Baseline - Study Eye
timeFrame: Week 16 and Week 56
measure: Number and Percentage (%) of Participants With Absence of Intra-retinal Fluid (IRF) From Baseline to Week 16 and Week 56 - for Patients Where IRF Was Present at Baseline - Study Eye
timeFrame: Week 16 and Week 56
measure: Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Absent at Baseline - Study Eye
timeFrame: Week 16 and Week 56
measure: Number and Percentage (%) of Participants With Absence of Sub-retinal Fluid (SRF) From Baseline to Week 16 and Week 56 - for Patients Where SRF Was Present at Baseline - Study Eye
timeFrame: Week 16 and Week 56
measure: Estimate CST Change From Baseline at Week 16 and Week 56 - Mean - Study Eye
timeFrame: Baseline, Week 16 and Week 56
measure: Estimate CST Change From Baseline at Week 16 and Week 56 - Median - Study Eye
timeFrame: Baseline, Week 16 and Week 56
Other outcomes:
Locations:
city: Asarwa
country: India
facility: Novartis Investigative Site
state: Ahmedabad
city: Ahmedabad
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Chennai
country: India
facility: Novartis Investigative Site
state: Tamilnadu
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: Varanasi
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Kolkatta
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Chandigarh
country: India
facility: Novartis Investigative Site
city: Hooghly
country: India
facility: Novartis Investigative Site
city: New Delhi
country: India
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
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