Assessing Combined Bevacizumab-Mitomycin C Use During Ahm... | NCT06983704

Studies
Assessing Combined Bevacizumab-Mitomycin C Use During Ahmed Valve Revision in Recurrent Pediatric Glaucoma

NCT06983704

Sponsor

Benha University

Status

Completed

Last Update Posted

May 21, 2025Actual

Enrollment

50Actual

Phase

Early Phase 1

Conditions

Pediatric Glaucoma

Interventions

AGV plate
bevacizumab injection

Countries

Egypt

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

ID	Type	Description	Link
Benha University	Other Identifier	Al-Azhar University

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2024Actual

Primary Completion Date

Feb 8, 2025Actual

Completion Date

Feb 15, 2025Actual

First Submitted Date

May 14, 2025

First Submission Date that Met QC Criteria

May 14, 2025

First Posted Date

May 21, 2025Actual

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

May 14, 2025

Last Update Posted Date

May 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To asess the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.

Detailed Description

Recurrent pediatric glaucoma following Ahmed Glaucoma Valve (AGV) implantation presents a therapeutic challenge. This study evaluates the efficacy and safety of combining subconjunctival bevacizumab with mitomycin C (MMC) during AGV revision surgery in pediatric patients with recurrent glaucoma.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I	Active Comparator	subconjunctival injection of bevacizumab was administered around the AGV plate using a 27-gauge needle	Procedure: AGV plate Procedure: bevacizumab injection
Group II	Active Comparator	AGV plate using a 27-gauge needle	Procedure: AGV plate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AGV plate	Procedure	AGV plate using a 27-gauge needle	Group I Group II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical success	IOP ≤ 21 mmHg and ≥ 5 mmHg without medications	for 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children under 12 years with previous AGV implantation for primary congenital glaucoma

Exclusion Criteria:

age >12 years, eyes with no light perception, and those with prior cyclodestructive procedures.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006871	Hydrophthalmos

Ancestor Terms

ID	Term
D005124	Eye Abnormalities
D005128	Eye Diseases
D005902	Glaucoma, Open-Angle
D005901	Glaucoma

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided