Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201655513401 Date of Approval: 17/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy and safety of four-weeks versus twelve-weeks loading doses spacing of intravitreal Aflibercept for treatment of macular edema associated with Central Retinal Vein Occlusion
Official scientific title Efficacy and safety of four-weeks versus twelve-weeks loading doses spacing of intravitreal Aflibercept for treatment of macular edema associated with Central Retinal Vein Occlusion
Brief summary describing the background and objectives of the trial The proposed research aims to answer the question about efficacy and safety of 4 weeks versus 12 weeks spacing of loading doses of intravitreal aflibercept for treatment of macular edema secondary to central retinal vein occlusion. The 4 weeks spacing is the conventional injection protocol used by many centres of injection worldwide. The 12 weeks spacing is used only in Egyptian General Authority for Health Insurance hospitals based on evidence reported in the literature that post aflibercept injection macular edema-free interval was as long as eight weeks or more. A randomized clinical trial will be conducted to answer the question and tell us which strategy results in better vision with lower number of injections after the one year follow up interval of those patients. aims of study:  At the end of the study, in which group the patients received a smaller number of injections with better visual acuity.  At the end of study, in which group, the patients received a smaller number of injections with best central macular thickness reduction documented by Heidelberg Spectralis Optical coherence tomography (OCT).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2022
Actual trial start date
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group intravitreal injection of aflibercipt each group receive at least 3 loading dose then as need one year follow up for each participant control group, each participant receives 3 loading doses of intravitreal aflibercept monthly spacing between doses then follow up for 9 months and during this period if the patient need another doses will be given as need. 30 Active-Treatment of Control Group
Experimental Group intravitreal injection of aflibercept 3 loading doses one year from 1st group each participant receives 3 loading doses of aflibercept with 12 weeks spacing between doses the follow up after 3rd dose for 3 months and if need for injection will given as need 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any participant to be included in the study should have: normal or controlled blood pressure. normal Hba1c or controlled (maximum 6.5%). normal or controlled lipogram. Patients aged ≥18 years with center-involved macular edema due to CRVO (CMT ≥250 µm on OCT). Best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) Exclusion criteria comprised the following: pregnancy or lactation. glaucoma. cataract. previous vitreoretinal or filtration surgery. iris neovascularization. any systemic or ocular disorder in the study eye that may confound the interpretation of the study results. previous treatment with any anti-VEGF agents. systemic anti-angiogenic medications. intraocular corticosteroids 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/01/2022 Assiut Faculty of Medicine. Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Asyut university, Asyut 71515, Egypt asyut 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Best corrected visual acuity changes at follow up time points. every 3 months
Secondary Outcome Changes in central macular thickness and choroidal thickness as measured by OCT. Reporting any ocular or systemic complications related to intravitreal injection of Aflibercept. every 3 months points
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Egypt health insurance 1 ali alobah street Asyut 71511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Egypt health insurance 1 Abu al-mahasen street, roksi, new Egypt, Cairo Cairo 11311 Egypt Egyptian health insurance
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abd El Nasser Awad Mohammad abdelnasser@aun.edu.eg +201064747230 Asyut university, Asyut 71515, Egypt
City Postal code Country Position/Affiliation
asyut 71511 Egypt Prof. Dr. Abd El Nasser Awad Mohammad. ophthalmology department. Asyut university. Asyut. Egypt.
Role Name Email Phone Street address
Public Enquiries Gamal El Deen Rashed gamaleldeen.rabea@med.au.edu.eg +201061822306 Asyut university 71515, Asyut, Egypt
City Postal code Country Position/Affiliation
Asyut 71511 Egypt Dr. Gamal El Deen Rashed. staff member ophthalmology department Asyut university
Role Name Email Phone Street address
Scientific Enquiries Hazem Abdel motaal Hazem hazem@aun.edu.eg +201000004312 Asyut university 71515,
City Postal code Country Position/Affiliation
Asyut 71511 Egypt Dr. Hazem Abdel motaal Hazem. staff member ophthalmology department Asyut university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all data of all participants will be collected during the trial until end of follow up Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately after publication, no end date investigators, statisticians
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not applicaple No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information