NCT06983704

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2024

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

February 9, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
Last Updated

May 21, 2025

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

May 14, 2025

Last Update Submit

May 14, 2025

Conditions

Pediatric Glaucoma

Keywords

Pediatric glaucomaAhmed valvebevacizumabmitomycin C

Outcome Measures

Primary Outcomes (1)

  • surgical success

    IOP ≤ 21 mmHg and ≥ 5 mmHg without medications

    for 12 months

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Procedure: AGV plateProcedure: bevacizumab injection

Group II

ACTIVE COMPARATOR

AGV plate using a 27-gauge needle

Procedure: AGV plate

Interventions

AGV platePROCEDURE

AGV plate using a 27-gauge needle

Group IGroup II
bevacizumab injectionPROCEDURE

subconjunctival injection of bevacizumab

Group I

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Hydrophthalmos

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesGlaucoma, Open-AngleGlaucomaOcular HypertensionCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 21, 2025

Study Start

February 9, 2024

Primary Completion

February 8, 2025

Study Completion

February 15, 2025

Last Updated

May 21, 2025

Record last verified: 2024-02

Locations

EG(1)