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Neovascular Age-related Macular DegenerationNCT05266495

Effectiveness of Brolucizumab in Pre-treated Patients With nAMD in the Real-world Setting

An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in United Arab Emirates.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study is a prospective and retrospective, observational, single-arm, non-randomized cohort study of ocular treatment with intravitreal injections of brolucizumab in nAMD patients. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Brolucizumab
Type of treatment
Injection or infusion
How many people
3 participants
Where
1 siteUnited Arab Emirates
Study dates
13 Apr 2022to 13 Mar 2023
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients that started brolucizumab treatment during the study recruitment period or patients that started brolucizumab treatment during the 6 months preceding the start of study recruitment

Who may be able to join

  • Diagnosis of nAMD
  • Patients with ≥18 years of age at index
  • Receipt of at least one injection of brolucizumab (not necessarily the first one) during the index period
  • Signed informed consent

Who cannot join

  • Patients treated for retinal vein occlusion (RVO), diabetic macular edema (DME), myopic choroidal neovascularization (mCNV), and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
  • Receipt of any anti-VEGF treatment other than brolucizumab in the study eye during the index period
  • Receipt of brolucizumab in the study eye more than 6 months before the index period, i.e., brolucizumab treatment started more than 6 months before the start of the study
  • Any active intraocular or periocular infection or active intraocular inflammation in the study eye at index date
  • Patients who have any contraindication and are not eligible for treatment with brolucizumab as according to the label
  • Patients who were treated with more than 2 types of anti-VEGF before index date (4th line brolucizumab patients or more)
Show all 9Show fewer
  • Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 12-month study participation
  • Patients participating in parallel in an interventional clinical trial Note: if a patient experiences an adverse event (AE), they may still be recruited in another study following this AE if they fulfill their inclusion criteria. Their data will still be collected as planned by the current protocol
  • Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • Novartis Investigative Site

    Abu Dhabi, 112412

Other trials in United Arab Emirates

About this study

Official title: Effectiveness of Brolucizumab in Pretreated Patients With nAMD in the Real-world Setting in Gulf Countries United Arab of Emirates, Kuwait , Bahrain , Oman and Qatar

The study is a prospective and retrospective, observational, single-arm, non-randomized cohort study of ocular treatment with intravitreal injections of brolucizumab in nAMD patients. This study will be conducted prospectively and retrospectively (for patients who had their first brolucizumab injection before study start) using data collected in a standardized manner.

Read the detailed description

Retrospective data will be collected for all patients starting treatment with brolucizumab for up to 12 months before baseline.

Patients who received brolucizumab before the study start will be recruited into the study and presented an informed consent form (ICF) at their first visit. Their index date will be the date of their first brolucizumab injection, which must have occurred during the recruitment period or in 6 months prior to the first visit in the recruitment period. Patient history and characteristics will be recorded in the 12 months prior to the index date.

Index date (Baseline): defined as the date of the first anti-VEGF injection (brolucizumab) in the patient study eye.

Index period: The patients fulfilling the inclusion criteria will be identified during the period 01-Nov-2021 and onwards.

Study period: The period is between May-2020 and Nov-2023 to allow 6-month pre-index period and at least a 12-month follow-up period for each recruited patient.

Being tested
Brolucizumab
Keywords
nAMD, brolucizumab, NIS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrolucizumabOther

    There is no treatment allocation. Patients administered brolucizumab by prescription will be enrolled.

Study groups in NCT05266495
Study groupRoleWhat they receive
Brolucizumabpatients who received their first injection of Brolucizumab either during the active recruitment period (1 year prospective) or during the 6 months pre-start of the recruitment (6 months retrospective)
Receives: Other: Brolucizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with absence of SRF and IRF

    percentage of treated patients with absence of SRF and IRF. Patients who have discontinued brolucizumab before Month 12 will be counted as not having achieved the endpoint of fluid resolution (absence of SRF and IRF), unless they reached it at the last visit while still on brolucizumab treatment before the discontinuation.

    Measured: Month 12

Secondary outcomes (68)

  1. Percentage of patients ≥ 80 years old

    Percentage of patients ≥ 80 years old will be collected

    Measured: Baseline

  2. Duration of diagnosis

    Time since first diagnosis (years) will be collected

    Measured: Baseline

  3. Percentage of patients with baseline visit

    Percentage of patients with baseline visit will be collected

    Measured: Baseline

  4. Percentage of patients with bilateral disease

    Percentage of patients with bilateral disease will be collected

    Measured: Baseline

  5. Percentage of patients with lesion type

    Percentage of patients by lesion type will be collected: occult, minimally classic, predominantly classic, other

    Measured: Baseline

  6. Percentage of patients with presence of SRF, IRF and sub-RPE

    It will be collected the percentage of patients with presence of:

    • Subretinal Fluid (SRF)
    • Intra-Retinal Fluid (IRF)
    • Subretinal Fluid (SRF) and/or Intra-Retinal Fluid (IRF)
    • Sub-Retinal Pigment Epithelium

    Measured: Baseline

  7. Baseline CST

    Central Subfield Thickness (CST) in μm will be collected

    Measured: Baseline, Month 3, Month 6, Month 9 and Month 12

  8. Baseline VA

    Visual Acuity (VA) will be measured with Early Treatment Diabetic Retinopathy Study (ETDRS) letters.

    Conversion of VA readings to approximate ETDRS Letters:

    For Snellen fraction decimal >0.025 (< logMAR1.60) the following formula is used: approximate ETDRS letters = 85+50*log10(Snellen fraction)

    For Snellen fractions decimal ≤ 0.025 four bins are defined:

    • > 0.020 to 0.025 (logMAR 1.70 to 1.60) is 5 letters
    • > 0.015 to 0.020 (logMAR 1.82 to 1.70) is 3 letters
    • > 0.005 to 0.015 (logMAR 2.30 to 1.82) is 1 letter
    • ≤ 0.005 (logMAR ≥ 2.30) is 0 letter

    Measured: Baseline

  9. Percentage of patients with the study eye that has VA equal or less than the VA in fellow eye

    Percentage of patients with the study eye that has Visual Acuity (VA) equal or less than the VA in fellow eye will be collected

    Measured: Baseline

  10. Percentage of patients with baseline VA in the following categories (≤35, 36-69, ≥ 70 ETDRS letters)

    Percentage of patients with baseline Visual Acuity (VA) in the following categories (≤35, 36-69, ≥ 70 ETDRS letters) will be collected

    Measured: Baseline

  11. Percentage of patients with VA between 34 and 72 ETDRS letters

    Percentage of patients with Visual Acuity (VA) within these values will be collected: 33 < VA < 73

    Measured: Baseline

  12. Percentage of patients with baseline VA < 73 ETDRS letters and active (SRF only)

    Percentage of patients with baseline VA < 73 ETDRS letters and active (SRF only) Active SRF is described as patients with new presence of SRF or increased SRF

    Measured: Baseline

  13. Percentage of patients with different ethnic groups

    Percentage of patients by ethnicity will be presented

    Measured: Baseline

  14. Switch Patients: Previous anti-VEGF treatments of nAMD pre-treated patients

    Previous anti-VEGF treatments of nAMD pre-treated patients will be collected

    Measured: Baseline

  15. Switch Patients: Duration of previous anti-VEGF treatments

    Duration of previous anti-VEGF treatments will be collected

    Measured: Baseline

  16. Switch Patients: Number of injections in the last year before switching to brolucizumab

    Number of injections in the last year before switching to brolucizumab will be collected

    Measured: Baseline

  17. Switch Patients: Last interval of anti-VEGF treatment before switching

    Last interval of anti-VEGF treatment before switching will be collected

    Measured: Baseline

  18. Percentage of patients with absence of SRF

    The total percentage of patients with absence of Subretinal Fluid (SRF) and percentage of patients with absence of SRF from those with presence of SRF at baseline will be collected

    Measured: Month 3, Month 6, Month 9 and Month 12

  19. Percentage of patients with stable SRF

    Percentage of patients with stable Subretinal Fluid (SRF), from those with absence of SRF at baseline

    Measured: Month 3, Month 6, Month 9 and Month 12

  20. Time to absence of SRF during the 12-month treatment with brolucizumab

    Time to absence of Subretinal Fluid (SRF) will be collected

    Measured: 12 months

  21. Percentage of patients with absence of IRF

    Percentage of patients with absence of Intra-Retinal Fluid (IRF), and percentage of patients with absence of IRF from those with presence of IRF at baseline will be collected

    Measured: Month 3, Month 6, Month 9 and Month 12

  22. Percentage of patients with stable IRF

    Percentage of patients with stable Intra-Retinal Fluid (IRF), from those with absence of IRF at baseline

    Measured: Month 3, Month 6, Month 9 and Month 12

  23. Time to absence of IRF during the 12-month treatment with brolucizumab

    Time to absence of Intra-Retinal Fluid (IRF) during the 12-month treatment with brolucizumab will be collected

    Measured: 12 months

  24. Percentage of patients with absence of sub-RPE

    Percentage of patients with absence of sub-Retinal Pigment Epithelium (RPE) and percentage of patients with absence of sub-RPE, from those with presence of sub-RPE at baseline will be collected

    Measured: Month 3, Month 6, Month 9 and Month 12

  25. Percentage of patients with stable sub-RPE

    Percentage of patients with stable sub-Retinal Pigment Epithelium (RPE), from those with absence of sub-RPE at baseline

    Measured: Month 3, Month 6, Month 9 and Month 12

  26. Time to absence of sub-RPE during the 12-month treatment with brolucizumab

    Time to absence of sub-Retinal Pigment Epithelium (RPE) during the 12-month treatment with brolucizumab will be collected

    Measured: 12 months

  27. Percentage of patients with absence of SRF, IRF and sub-RPE

    Percentage of patients with absence of Subretinal Fluid (SRF), Intra-Retinal Fluid (IRF) and sub-Retinal Pigment Epithelium (RPE) and percentage of patients with absence of SRF and IRF and sub-RPE, from those with presence of SRF or IRF or sub-RPE at baseline will be collected

    Measured: Month 3, Month 6, Month 9 and Month 12

  28. Time to absence of IRF and SRF and sub-RPE during the 12-month treatment with brolucizumab

    Time to absence of IRF and SRF and sub-RPE during the 12-month treatment with brolucizumab

    Measured: 12 months

  29. Estimate CST change from baseline

    Estimate Central Subfield Thickness (CST) change from baseline (in μm) will be collected

    Measured: Month 3, Month 6, Month 9 and Month 12

  30. Percentage of patients with reduced CST vs baseline

    Percentage of patients with reduced CST vs baseline will be collected

    Measured: Baseline, Month 3, Month 6, Month 9 and Month 12

  31. Association between CST variability at Months 1-12 and VA change from baseline

    Correlation statistical tests between CST variability at Months 1-12 (quartiles) and VA change from baseline to Months 3, 6, 9 and 12

    Measured: Month 3, Month 6, Month 9 and Month 12

  32. Association between CST variability at Months 1-12 and number of injections

    Correlation statistical tests between CST variability at Months 1-12 (quartiles) and number of injections during the 12-month treatment with brolucizumab

    Measured: Month 12

  33. Percentage of patients with clinician-graded subretinal fibrosis and/or macular atrophy

    Percentage of patients with clinician-graded subretinal fibrosis and/or macular atrophy

    Measured: Month 12

  34. VA change from baseline

    Visual Acuity (VA) change from baseline (in ETDRS letters)

    Measured: Baseline, Month 3, Month 6, Month 9 and Month 12

  35. Percentage of patients with VA change from baseline

    Percentage of patients with Visual Acuity (VA) change from baseline categorized as: ≤ -20, ≤ -15, (-15, -10], (-10, -5], (-5, 5), [5, 10), [10, 15), ≥ 15, ≥ 20 (in ETDRS letters)

    Measured: Baseline, Month 3, Month 6, Month 9 and Month 12

  36. Percentage of patients with ≥ 70 ETDRS letters

    Percentage of patients with ≥ 70 ETDRS letters will be collected

    Measured: Month 3, Month 6, Month 9 and Month 12

  37. Number of brolucizumab visits

    Number of brolucizumab injections, non-injection visits and total number of visits will be collected

    Measured: Over Months 1-3, 3-6, 6-12 and 1-12

  38. Distribution of injection intervals

    Distribution of injection intervals < 4; [4, 6); [6, 8); [8, 10); [10, 12); ≥12 weeks will be collected

    Measured: During Months 1-6 and 1-12

  39. Percentage of patients with at least one duration of interval between injections

    Percentage of patients with at least one duration of interval between injections < 4; [4, 6); [6, 8); [8, 10); [10, 12); ≥ 12 weeks (the maximum injection interval will be kept) One duration of interval is defined as the time between one injection and the following one

    Measured: 12 months

  40. Percentage of patients with at least two consecutive duration of intervals between injections

    Percentage of patients with at least two consecutive duration of intervals between injections < 4; [4, 6); [6, 8); [8, 10); [10, 12); ≥12 weeks (the maximum duration will be kept) Two consecutive duration of intervals is the time between one injection and the second consecutive one.

    Measured: 12 months

  41. Percentage of switch patients from other anti-VEGF that prolonged injection intervals with brolucizumab

    Percentage of switch patients from other anti-VEGF that prolonged injection intervals with brolucizumab will be collected

    Measured: Month 6, Month 9 and Month 12

  42. Percentage of patients with ≥ 3 brolucizumab injections

    Percentage of patients with ≥ 3 brolucizumab injections will be collected

    Measured: Month 3

  43. Number of participants by last recorded injection interval

    Number of participants by last recorded injection interval (in weeks)

    Measured: Month 6 and Month 12

  44. Time between two consecutive brolucizumab injections

    Time (in days) between two consecutive brolucizumab injections will be collected

    Measured: Over Months 1-3

  45. Number of visits with/without OCT

    Number of visits with/without Optical Coherence Tomography (OCT) will be collected

    Measured: Over Months 1-6 and 1-12

  46. Association between number of OCT and CNV activity

    Correlation statistical tests between number of Optical Coherence Tomography (OCT) (0-1, 2-3, ≥ 4) and Choroidal Neovascularization (CNV) activity [active, active (SRF only), inactive]

    Measured: Month 6, Month 9 and Month 12

  47. Association between number of OCT and VA change from baseline

    Correlation statistical tests between number of Optical Coherence Tomography (OCT) (0-1, 2-3, ≥ 4) and Visual Acuity (VA) change from baseline (in ETDRS letters)

    Measured: Month 6, Month 9 and Month 12

  48. Association between number of OCT and number of injections

    Correlation statistical tests between number of Optical Coherence Tomography (OCT) (0-1, 2-3, ≥ 4) at Months 6, 9 and 12 and number of injections during the Months 1-6, 1-9 and 1-12 of treatment with brolucizumab

    Measured: 12 months

  49. proportion of participants by baseline CNV activity

    Baseline Choroidal Neovascularization (CNV) activity (active, active (SRF only), inactive) will be collected

    Measured: Baseline

  50. Proportion of participants with and without Loading phase

    Proportion of participants with and without Loading phase will be collected. Loading phase (yes/no) defined as ≥ 3-injections within 90 days post-index

    Measured: 12 months

  51. VA at the end of the loading phase

    Visual Acuity (VA) at the end of the loading phase will be collected. Loading phase is defined as ≥ 3-injections within 90 days post-index

    Measured: Month 3

  52. CNV activity at the end of the loading phase

    Choroidal Neovascularization (CNV) activity at the end of the loading phase (active, active (SRF only), inactive) will be measured.

    Loading phase is defined as ≥ 3-injections within 90 days post-index

    Measured: Month 3

  53. Number of injections during the maintenance phase

    Number of injections during the maintenance phase will me measured

    Measured: Over months 3-12

  54. Percentage of patients with geographic atrophy

    Percentage of patients with geographic atrophy will be measured

    Measured: 12 Months

  55. Percentage of patients with subretinal fibrosis

    Percentage of patients with subretinal fibrosis will be measured

    Measured: 12 Months

  56. Assessment of criteria for no retreatment

    Percentage of patients by criteria for no retreatment will be measured. ( i.e., disease activity assessed by: VA, anatomic parameters, predetermined by regimen, other (e.g., organizational, patient choice, etc.)

    Measured: 12 months

  57. Percentage of patients who switch to another anti-VEGF

    Percentage of patients who switch to another anti-VEGF during the first 6, 9 and 12 months of treatment with brolucizumab will be measured

    Measured: 6 Months, 9 Months and 12 Months

  58. VA at time of switch

    Visual Acuity (VA) at time of switch will be measured with Early Treatment Diabetic Retinopathy Study (ETDRS) letters.

    Measured: Up to 12 months

  59. Percentage of patients with activity at time of switch

    Percentage of patients with activity at time of switch:

    • Intra-Retinal Fluid (IRF) activity
    • Subretinal Fluid (SRF) activity
    • sub-Retinal Pigment Epithelium (RPE) activity
    • Central Subfield Thickness (CST) activity
    • Choroidal Neovascularization (CNV) activity

    Measured: Up to 12 months

  60. Percentage of switchers with full loading phase

    Percentage of switchers with full loading phase will be collected Loading phase (yes/no) defined as ≥ 3-injections within 90 days post-index

    Measured: 12 months

  61. Percentage of patients by injection rate at pre-switch period

    Percentage of patients by injection rate at pre-switch period will be collected

    Measured: Up to 12 months

  62. Reason for switching to another anti-VEGF

    Percentage of patients by reason for switching to another anti-VEGF will be collected

    Measured: 12 months

  63. Last recorded injection interval before switching

    Last recorded injection interval (in weeks) before switching will be collected

    Measured: Month 6 and Month 12

  64. Duration of brolucizumab treatment before switching

    Duration of brolucizumab treatment before switching will be collected

    Measured: Up to month 12

  65. Percentage of patients who discontinue therapy

    Percentage of patients who discontinue therapy and reasons for discontinuation. Discontinuation is defined as if anti-VEGF brolucizumab was stopped (including treatment switch to another anti-VEGF) at some point and never re-introduced for at least 180 days, while the patient has at least one clinical or anatomical assessment during that period

    Measured: Up to 12 months

  66. Days of persistence

    Persistence is defined as the time (in days) on drug from from the initiation of anti-VEGF therapy with brolucizumab to its discontinuation (defined as injection gap of >180 days)

    Measured: Up to 12 Months

  67. Percentage of patients with AEs

    Percentage of patients with AEs will be collected

    Measured: 12 Months

  68. AE rate

    AE rate (per 10,000 injections) will be collected

    Measured: Month 3, Month 6, Month 9 and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start13 Apr 2022
  3. Primary completion13 Mar 2023
  4. Study completion13 Mar 2023

Why it stopped: Company Decision

Resources

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
Other
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266495
Sponsor's protocol ID
CRTH258AAE01
Status last verified
Mar 2024
First submitted
23 Feb 2022
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in United Arab Emirates.

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 9 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: stopped early, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. 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 was stopped early (reason given: Company Decision). Results are not available in the source record.

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 of SRF and IRF (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266495.

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 13 Jan 2025.

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