NCT05251636

Brief Summary

This study is investigating the use of episcleral brachytherapy (ESB) adjunct to aflibercept compared to aflibercept monotherapy for the treatment of polyploid choroidal vasculopathy (PCV) in patients experiencing an inadequate response to anti-VEGF monotherapy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
159

participants targeted

Target at P25-P50 for phase_3

Timeline
29mo left

Started Mar 2025

Typical duration for phase_3

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Mar 2025Sep 2028

First Submitted

Initial submission to the registry

February 11, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
3 years until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

February 11, 2022

Last Update Submit

August 28, 2023

Conditions

Age-Related Macular DegenerationPolypoid Choroidal Vasculopathy

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual Acuity (BCVA)

    12 months

Secondary Outcomes (3)

  • Best Corrected Visual Acuity (BCVA)

    24 months

  • Central Retinal Thickness

    12 and 24 months

  • Lesion size

    12 and 24 months

Study Arms (2)

ESB adjunct to IAI

EXPERIMENTAL

Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)

Radiation: Episcleral BrachytherapyDrug: Aflibercept Injection

IAI monotherapy

ACTIVE COMPARATOR

Intravitreal aflibercept injections (IAI)

Drug: Aflibercept Injection

Interventions

Episcleral BrachytherapyRADIATION

Minimally invasive, single fraction brachytherapy

ESB adjunct to IAI
Aflibercept InjectionDRUG

Standard of Care intravitreal aflibercept injection

ESB adjunct to IAIIAI monotherapy

Eligibility Criteria

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

You may qualify if:

  • Active PCV due to nAMD
  • Incomplete response to anti-VEGF
  • Received at least 3 consecutive and sequential anti-VEGF injections (no missed treatments)
  • Ability to undergo ESB intervention

You may not qualify if:

  • Sub-retinal fibrosis
  • Type I or Type II diabetes mellitus
  • Previous therapeutic radiation to the head or neck that may have resulted in radiation dose to the retina
  • Study eye with BCVA of worse than 20 ETDRS letters (20/400 Snellen)
  • Fellow eye with worse BCVA than the study eye or other vision-threatening disease not eligible for treatment
  • Receiving anti-VEGF therapy for any reason other than AMD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Central Study Contacts

Mary Drew

CONTACT

5206387518mdrew@salutarismd.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2022

First Posted

February 23, 2022

Study Start

March 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

August 30, 2023

Record last verified: 2023-08