Clincosm LogoSign in Get a demo

A Dosing Study of Intravitreal Bevacizumab for Retinopathy of Prematurity

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05712642
Collaborator
(none)
19
Enrollment
1
Location
2
Arms
11.9
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravitreal Bevacizumab
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Dosing Study of Two Different Doses (0.3125mg Versus 0.625mg) Intravitreal Bevacizumab for Type 1 ROP (Retinopathy of Prematurity)
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Jan 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 .

Drug: Intravitreal Bevacizumab
Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
Other Names:
  • Avastin

    		•
    Active Comparator: 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 .

    Drug: Intravitreal Bevacizumab
    Serum systemic level of VEGF was measured before and after 1 week and 4 weeks of intravitreal injection of bevacizumab
    Other Names:
  • Avastin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the serum systemic VEGF pre- and post- intravitreal injection of bevacizumab in both groups. [at day 0 (baseline ) , 1 week and 4 weeks post-injection]

      serum systemic VEGF measured using human VEGF ELISA kit

    2. The number of infants without need for rescue therapy until 60 weeks of postmenstrual age after initial treatment. ["up to 60 weeks postmenstrual age"]

      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.

    Secondary Outcome Measures

    1. Occurrence of any adverse events from intravitreal-injection [Within 4 weeks from intravitreal injection]

      endophthalmitis , retinal detachment , cataract , vitreous hemorrhage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Weeks to 40 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Cairo University Cairo Egypt 11865

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Nooran Abdelkader, MD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nooran Mohammed Abdelhameed Abdelkader, Assistant lecturer ophthalmology department Cairo university, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05712642
    Other Study ID Numbers:
    • MD-108-2019
    First Posted:
    Feb 3, 2023
    Last Update Posted:
    Feb 3, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Retinal Diseases
    Retinopathy of Prematurity
    Premature Birth
    Bevacizumab

    Study Results

    No Results Posted as of Feb 3, 2023