Adjunct Episcleral Brachytherapy for PCV | NCT05251636

Studies
Adjunct Episcleral Brachytherapy for PCV

NCT05251636

Sponsor

Salutaris Medical Devices, Inc.

Status

Not yet recruiting

Last Update Posted

Aug 30, 2023Actual

Enrollment

159Estimated

Phase

Phase 3

Conditions

Age-Related Macular Degeneration
Polypoid Choroidal Vasculopathy

Interventions

Episcleral Brachytherapy
Aflibercept Injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2025Estimated

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2028Estimated

First Submitted Date

Feb 11, 2022

First Submission Date that Met QC Criteria

Feb 21, 2022

First Posted Date

Feb 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2023

Last Update Posted Date

Aug 30, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

159Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESB adjunct to IAI	Experimental	Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)	Radiation: Episcleral Brachytherapy Drug: Aflibercept Injection
IAI monotherapy	Active Comparator	Intravitreal aflibercept injections (IAI)	Drug: Aflibercept Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Episcleral Brachytherapy	Radiation	Minimally invasive, single fraction brachytherapy	ESB adjunct to IAI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity (BCVA)		12 months

Secondary Outcomes

Measure	Description	Time Frame
Best Corrected Visual Acuity (BCVA)		24 months
Central Retinal Thickness		12 and 24 months
Lesion size

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Mary Drew	Contact	5206387518		mdrew@salutarismd.com

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C533178	aflibercept

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided