A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

NCT ID: NCT05712642

Last Updated: 2023-02-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-01-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of our study was to determine whether a low dose of 0.3125mg intravitreal bevacizumab is effective in treatment of type 1 ROP as the standard 0.625 mg dose., regarding :

Serum Systemic VEGF levels. Retinal Vascularization.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinopathy of Prematurity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A recieved 0.3125mg intravitreal bevacizumab in both eyes

9 infants in group A with type 1 ROP , received 0.3125mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection .

Group Type EXPERIMENTAL

Intravitreal Bevacizumab

Intervention Type DRUG

Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab

Group B received 0.625mg intravitreal bevacizumab in both eyes

10 infants in group B with type 1 ROP , received 0.625mg IVI of bevacizumab in both eyes, serum systemic levels of VEGF was measured at day 0 (before injection) , and 1 week and 4 weeks post injection .

Group Type ACTIVE_COMPARATOR

Intravitreal Bevacizumab

Intervention Type DRUG

Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravitreal Bevacizumab

Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Avastin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Infants with Type 1 ROP according to ETROP study which is defined as:

* Zone I ROP with plus disease
* Zone I, stage 3 ROP without plus disease
* Zone II, stage 2 or 3 ROP with plus disease

Exclusion Criteria

* Eyes with previous intravitreal injection
* Eyes with previous laser therapy
* Eyes with any other intraocular pathology other than ROP (congenital cataract, congenital glaucoma, any retinal pathology other than ROP)
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nooran Mohammed Abdelhameed Abdelkader

Assistant lecturer ophthalmology department Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nooran Abdelkader, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine Cairo University

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MD-108-2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intravitreal Bevacizumab for Diabetic Retinopathy
NCT00600262 TERMINATED PHASE2/PHASE3
Dacorin for Proliferative Vitreoretinopathy
NCT02865031 COMPLETED PHASE1/PHASE2