A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

NCT05712642 | Completed Phase 3

• 1 other identifier: MD-108-2019
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (2)

• Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups.

  serum systemic VEGF measured using human VEGF ELISA kit

  at day 0 (baseline ) , 1 week and 4 weeks post-injection

• The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment.

  Rescue therapy is defined as the need of a second dose of 0.625 mg bevacizumab reinjection or laser at any time during follow up period.

  "up to 60 weeks postmenstrual age"

Secondary Outcomes (1)

• Occurrence of any adverse events from intravitreal-injection

  Within 4 weeks from intravitreal injection

Study Arms (2)

Group A recieved 0.3125mg intravitreal bevacizumab in both eyes

EXPERIMENTAL

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 .

Drug: Intravitreal Bevacizumab

Group B received 0.625mg intravitreal bevacizumab in both eyes

ACTIVE COMPARATOR

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 .

Drug: Intravitreal Bevacizumab

Interventions

Intravitreal Bevacizumab DRUG

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

Also known as: Avastin

Group A recieved 0.3125mg intravitreal bevacizumab in both eyes; Group B received 0.625mg intravitreal bevacizumab in both eyes

Eligibility Criteria

• Age: 28 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Nooran Abdelkader, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer ophthalmology department Cairo university

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 3, 2023
• Study Start: February 1, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 28, 2021
• Last Updated: February 3, 2023

Record last verified: 2023-02

Locations

EG (1)