NCT04698850

Brief Summary

This is a prospective randomised study comparing two intravitreal antiVEGF drugs - brolucizumab and aflibercept - in the treatment of retinal angiomatous proliferation (RAP). Patients with RAP confirmed on optical coherence tomography (OCT) and on OCT angiography (OCTA) will be randomised in two groups and followed for 52 weeks. Patients in the first group will receive aflibercept - 3 injections monthly for the first 3 months and then in treat-and-extend regimen with minimal interval of 8 weeks and maximal interval of 16 weeks. Extension or shortening of the therapeutic interval will be possible in 2 or 4 week increments based on the visual acuity and disease activity assessed on OCT. Patients in the second group will receive brolucizumab - 3 injections monthly in the first 3 months and then every 2 or 3 months based on the visual acuity and disease activity assessed on OCT. Best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT and number of injections will be compared between both groups.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

January 5, 2021

Last Update Submit

August 7, 2022

Conditions

Wet Macular Degeneration

Keywords

wet age-related macular degenerationretinal angiomatous proliferationafliberceptbrolucizumab

Outcome Measures

Primary Outcomes (3)

  • Best corrected visual acuity

    BCVA change from baseline to week 52.

    Baseline and week 52

  • Central retinal thickness

    CRT change from baseline to week 52.

    Baseline and week 52

  • Number of injections

    Average number of injections per patient in each group.

    Week 52

Secondary Outcomes (5)

  • Dry macula

    Week 52

  • Significant visual gain

    Week 52

  • Significant visual loss

    Week 52

  • Adverse events

    Week 52

  • Rescue

    Week 52

Study Arms (2)

aflibercept

ACTIVE COMPARATOR

Patients with RAP who will be receiving aflibercept.

Drug: Aflibercept 40 MG/ML [Eylea]Drug: Ranibizumab 6 MG/ML [Lucentis]

brolucizumab

EXPERIMENTAL

Patients with RAP who will be receiving brolucizumab.

Drug: Brolucizumab-Dbll 120 MG/ML [Beovu]Drug: Ranibizumab 6 MG/ML [Lucentis]

Interventions

Aflibercept 40 MG/ML [Eylea]DRUG

Patients will be receiving intravitreal aflibercept starting with 3 monthly doses and continuing with treat-and-extend regimen with minimal interval of 8 week and maximum interval of 16 week. Interval can be prolonged or shortened by 2 or 4 weeks based on the disease activity and BCVA..

Also known as: Eylea
aflibercept
Brolucizumab-Dbll 120 MG/ML [Beovu]DRUG

Patients will be receiving intravitreal brolucizumab starting with 3 monthly doses followed by the treatment interval of 8 or 12 weeks based on the disease activity and BCVA.

Also known as: Beovu
brolucizumab
Ranibizumab 6 MG/ML [Lucentis]DRUG

Rescue therapy for patients with study drug related adverse events or with worsening of BCVA and OCT finding even on the shortest treatment interval when resistance to study drug is suspected.

Also known as: Lucentis
afliberceptbrolucizumab

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age of 50 years or more at the time the informed consent is signed
  • active RAP in the macula including fovea diagnosed on OCT and OCTA
  • BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent)
  • decrease in BCVA caused primarily by the RAP in the study eye
  • presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT
  • patient capable of signing the informed consent

You may not qualify if:

  • other causes of choroidal neovascular membrane (CNV) than wAMD
  • previous or current conditions of the study eye:
  • subretinal haemorrhage comprising more than 25% of the lesion in the study eye
  • scar or fibrosis comprising more than 50% of the lesion in the study eye
  • presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
  • total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
  • uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
  • idiopathic or autoimmune uveitis in the study eye
  • other pathologies in the macula of the study eye which can be expected to influence the BCVA (e.g. macular hole, retinal atrophy, epiretinal membrane, etc.)
  • history of glaucoma surgery in the study eye or probability that it will be necessary in the future
  • aphakia or pseudophakia with absence of the posterior lens capsule (with the exception of missing posterior capsule due to Nd:YAG laser capsulotomy) in the study eye
  • myopia in the study eye with spherical equivalent of more than 8 dioptries before any refractive or cataract surgery
  • significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or FP or OCT examination
  • corneal transplantation or corneal dystrophy in the study eye
  • irregular astigmatism or BCVA-lowering amblyopia in the study eye
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Faculty hospital Kralovske Vinohrady

Prague, 100 34, Czechia

Location

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

afliberceptRanibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Martin Pencak, M.D.

    Faculty Hospital Kralovske Vinohrady

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2021

First Posted

January 7, 2021

Study Start

January 4, 2021

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)