Neurovascular Age-related Macular DegenerationNCT05834075
A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India
An observational study of Neurovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 4 sites in India.
Trial summary
This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neurovascular Age-related Macular Degeneration
- How many people
- 63 participants
- Where
- 4 sitesIndia
- Study dates
- 5 Jan 2022to 22 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- Treatment-naïve nAMD patients or patients previously treated with a single or a combination of other intravitreal anti-VEGFs
- Patients (male or female) ≥50 years of age at the index date
- Patients with visual acuity (VA) and optical coherence tomography (OCT) assessments at baseline and at least 1 month after initiating treatment with brolucizumab
- Patients treated with IVI of brolucizumab (received the first dose of anti-VEGF injection during the index period [01 October 2020 to 31 March 2021])
Who cannot join
- Patients with dry AMD, geographic atrophy, and other retinal diseases in the study eye
- Patients who were part of any other nAMD trial/study during the study period
- Patients undergoing additional ocular treatment along with other anti-VEGF agents
Trial locations and contacts
4 sites in 1 country.
India4 sites
Narayana Nethralaya
Bangalore
Disha Eye Hospital
Kolkata
Susrut Eye Foundation and Research Center
Kolkata
Dr. Milan's Retina Care Center
Rajkot
About this study
This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Anonymized data of patients treated with brolucizumab intravitreal injection (IVI) who had received the first dose of brolucizumab between 01 October 2020 and 31 March 2021 was collected. Patients could either be treatment-naïve or previously treated with single or a combination of other IVI of anti-vascular endothelial growth factors (VEGFs). The primary outcome measure was the change in fluid levels (intra-retinal fluid [IRF], sub-retinal fluid [SRF], and pigment epithelial detachment [PED]) from baseline to Month 3. Secondary outcome measures included change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), number of brolucizumab injections, and safety (number of adverse events [AEs]). Descriptive statistics were tabulated for the demographic and clinical characteristics as well as outcome variables.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline
Percentage of patients with either absence of intra-retinal fluid (IRF) at Month 3 or a reduction of IRF at Month 3 compared to baseline.
Measured: From baseline to Month 3
Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline
Percentage of patients with either absence of sub-retinal fluid (SRF) at Month 3 or a reduction of SRF at Month 3 compared to baseline.
Measured: From baseline to Month 3
Percentage of patients with absence or reduction of PED at Month 3 compared to baseline
Percentage of patients with either absence of pigment epithelial detachment (PED) at Month 3 or a reduction of PED at Month 3 compared to baseline.
Measured: From baseline to Month 3
Secondary outcomes (9)
Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR)
Measured: Baseline and Month 3
Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline
Measured: Baseline, Months 1 and 2
Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline
Measured: Baseline, Months 1 and 2
Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline
Measured: Baseline, Months 1 and 2
Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT)
Measured: Baseline, Months 1, 2, and 3
Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment
Measured: Months 1, 2, and 3
Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment
Measured: Months 1, 2, and 3
Number of visits during Months 1, 2, and 3 of brolucizumab treatment
Measured: Months 1, 2, and 3
Number of patients with treatment-emergent adverse events
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start5 Jan 2022
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834075
- Sponsor's protocol ID
- CRTH258AIN02
- Status last verified
- Apr 2023
- First submitted
- 19 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India
- ClinicalTrials.gov ID
- NCT05834075
- Acronym / sponsor ID
- CRTH258AIN02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Anonymized data of patients treated with brolucizumab intravitreal injection (IVI) who had received the first dose of brolucizumab between 01 October 2020 and 31 March 2021 was collected. Patients could either be treatment-naïve or previously treated with single or a combination of other IVI of anti-vascular endothelial growth factors (VEGFs). The primary outcome measure was the change in fluid levels (intra-retinal fluid [IRF], sub-retinal fluid [SRF], and pigment epithelial detachment [PED]) from baseline to Month 3. Secondary outcome measures included change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), number of brolucizumab injections, and safety (number of adverse events [AEs]). Descriptive statistics were tabulated for the demographic and clinical characteristics as well as outcome variables.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (4 listed)
- Treatment-naïve nAMD patients or patients previously treated with a single or a combination of other intravitreal anti-VEGFs
- Patients (male or female) ≥50 years of age at the index date
- Patients with visual acuity (VA) and optical coherence tomography (OCT) assessments at baseline and at least 1 month after initiating treatment with brolucizumab
- Patients treated with IVI of brolucizumab (received the first dose of anti-VEGF injection during the index period [01 October 2020 to 31 March 2021])
Key exclusion criteria (3 listed)
- Patients with dry AMD, geographic atrophy, and other retinal diseases in the study eye
- Patients who were part of any other nAMD trial/study during the study period
- Patients undergoing additional ocular treatment along with other anti-VEGF agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline
Time frame: From baseline to Month 3
Percentage of patients with either absence of intra-retinal fluid (IRF) at Month 3 or a reduction of IRF at Month 3 compared to baseline.
Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline
Time frame: From baseline to Month 3
Percentage of patients with either absence of sub-retinal fluid (SRF) at Month 3 or a reduction of SRF at Month 3 compared to baseline.
Percentage of patients with absence or reduction of PED at Month 3 compared to baseline
Time frame: From baseline to Month 3
Percentage of patients with either absence of pigment epithelial detachment (PED) at Month 3 or a reduction of PED at Month 3 compared to baseline.
9 secondary outcomes
Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR)
Time frame: Baseline and Month 3
Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline
Time frame: Baseline, Months 1 and 2
Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline
Time frame: Baseline, Months 1 and 2
Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline
Time frame: Baseline, Months 1 and 2
Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT)
Time frame: Baseline, Months 1, 2, and 3
Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment
Time frame: Months 1, 2, and 3
Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment
Time frame: Months 1, 2, and 3
Number of visits during Months 1, 2, and 3 of brolucizumab treatment
Time frame: Months 1, 2, and 3
Number of patients with treatment-emergent adverse events
Time frame: Baseline to Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline (time frame: From baseline to Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.