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

NCT ID: NCT06983704

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-09

Study Completion Date

2025-02-15

Brief Summary

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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

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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.

Conditions

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Pediatric Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group I

subconjunctival injection of bevacizumab was administered around the AGV plate using a 27-gauge needle

Group Type ACTIVE_COMPARATOR

AGV plate

Intervention Type PROCEDURE

AGV plate using a 27-gauge needle

bevacizumab injection

Intervention Type PROCEDURE

subconjunctival injection of bevacizumab

Group II

AGV plate using a 27-gauge needle

Group Type ACTIVE_COMPARATOR

AGV plate

Intervention Type PROCEDURE

AGV plate using a 27-gauge needle

Interventions

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AGV plate

AGV plate using a 27-gauge needle

Intervention Type PROCEDURE

bevacizumab injection

subconjunctival injection of bevacizumab

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ehab Mohamed Elsayed Mohamed Saad

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Benha University

Identifier Type: OTHER

Identifier Source: secondary_id

Bevacizumab-MMC

Identifier Type: -

Identifier Source: org_study_id

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