Ranibizumab Versus Aflibercept for CRVO in Young Patients. | NCT05282420

Studies
Ranibizumab Versus Aflibercept for CRVO in Young Patients.

NCT05282420

Sponsor

South Valley University

Status

Unknown status

Last Update Posted

Mar 16, 2022Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Non-Ischemic Central Retinal Vein Occlusion With Macular Edema

Interventions

intravitreal injection of Ranibizumab
intravitreal injection of Aflipercept
Ranibizumab
Aflibercept

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

May 31, 2022Estimated

First Submitted Date

Mar 4, 2022

First Submission Date that Met QC Criteria

Mar 15, 2022

First Posted Date

Mar 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2022

Last Update Posted Date

Mar 16, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Ali Ahmed Amer, Ophthalmology department Qena Faculty of medicine, South Valley University, Egypt, South Valley UniversityPrincipal Investigator

Lead Sponsor

South Valley UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

this study will compare the efficacy and safety of use either Ranibizumab and Aflibercept in treatment of macular edema resulting from non ischemic central retinal vein occlusion in patients younger than 5o years old

Detailed Description

This is a prospective randomized interventional study, Forty eyes of forty patients younger than 50 years with macular edema due to non-ischemic CRVO were enrolled in the study.

Patients will be randomized into 2 groups. First group will receive intravitreal injection of Ranibizumab 0.5 mg\0.1ml. the second group will receive intravitreal injection of 2.0 mg\0.1 ml Aflibercept. All patients will be followed up for 12 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ranibizumab group	Active Comparator	Ranibizumab injection monthly for 3 successive months	Procedure: intravitreal injection of Ranibizumab Drug: Ranibizumab
Aflibercept group	Active Comparator	Aflibercept injection monthly for 3 successive months	Procedure: intravitreal injection of Aflipercept Drug: Aflibercept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intravitreal injection of Ranibizumab	Procedure	intravitreal injection of Anti-VEGF Ranibizumab (Lucentis®; manufactured in the United States by Genentech/Roche)	Ranibizumab group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity BCVA	change BCVA after injection	at 12 months post-injection

Secondary Outcomes

Measure	Description	Time Frame
reduction of macular edema	change in central subfield macular thickness CST on OCT	at 12 months post-injection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients younger than 50 years with macular edema due to non-ischemic CRVO

Exclusion Criteria: Other conditions that might affect the macula as

diabetic retinopathy, intraocular inflammation, age related macular degeneration, patients with solar or radiation retinopathy,
patients with ischemic type CRVO and patients who had recent intraocular surgery.
patients who had previous intravitreal injections, ophthalmic laser surgeries.
patients with dense cataracts whom fundus was difficult to scan.
Patients who were lost to follow up visits were also excluded

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Ali Ahmed Amer	Recruiting	Qina	Qena Governorate	83523	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008269	Macular Edema

Ancestor Terms

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab
C533178	aflibercept

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Patients were randomized into two groups, twenty patients (20 eyes) each. The first group received 0.5 mg\0.1 ml ranibizumab intravitreal injections and the second group received 2.0 mg\0.1 ml aflibercept intravitreal injections. all patients were followed up for at least 12 months.

Patients were given the planned treatment throughout the study and no switching was done between anti-VEGF drugs