Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity

NCT05033106 | Unknown Phase 3 DMC

• 1 other identifier: D-9-2020
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.

Conditions

Retinopathy of Prematurity Both Eyes

Outcome Measures

Primary Outcomes (1)

• • Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age.

  regression of plus disease and the active neovessels

  60 weeks PMA

Secondary Outcomes (1)

• • Recurrence of ROP

  60 weeks PMA

Other Outcomes (3)

• • The number and kind of adverse events, the number of patients progressing to stage 4 or 5.

  60 weeks PMA

• • The number of reinjections or laser spots and the number of eyes that need lensectomy and vitrectomy.

  60 weeks PMA

• • Refractive errors in spherical equivalent in patients who only received anti-VEGF treatment, pattern of fixation and ocular alignment.

  60 weeks PMA

Study Arms (2)

Eyes with IVI bevacizumab

ACTIVE COMPARATOR

0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye

Drug: Bevacizumab, Ranibizumab

Eyes with IVI ranibizumab

ACTIVE COMPARATOR

A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant

Drug: Bevacizumab, Ranibizumab

Interventions

Bevacizumab, Ranibizumab DRUG

• A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant and 0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye 1 mm posterior to the superior/inferior temporal limbus via 30 G needle. The two injections are done sequentially on two consecutive days starting with the eye of more advanced disease.

Also known as: avastin, leucentis

Eyes with IVI bevacizumab; Eyes with IVI ranibizumab

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Infants with a birth weight of ≤ 1500 g or geststional age of ≤ 30 weeks and selected infants with birth weight between 1500 and 2000 g or gestational age of more than 30 weeks with an unstable clinical course, including those requiring cardiorespiratory support. Patients with bilateral disease who will receive bilateral injections, are only included. 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 and Zone II, stage 2 or 3 ROP with plus disease.

You may not qualify if:

• Eyes with previous intravitreal injections. Eyes with previous laser therapy. Eyes with any other pathology, other than ROP. Eyes with ROP stage 4 or 5. Eyes with mucopurulent or purulent conjunctivitis. Infants who will not be able to comply to the follow-up schedule.

Sponsors & Collaborators

• Zagazig University: lead
• Cairo University: collaborator

Study Sites (1)

Zagazig University

Zagazig, 002055, Egypt

RECRUITING

MeSH Terms

Interventions

Bevacizumab; Ranibizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ghada Mahmoud Tawfik Eladawy, Msc

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada Mahmoud Tawfik Eladawy, Msc

CONTACT

00201006780358; dr_ghadaeladawy@yahoo.com

Sherif Abbas Dabour, MD

CONTACT

00201001748689; daboursh490@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr ghadaeladawy@yahoo.com

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: two years
• Access Criteria: Internet

Locations

EG (1)