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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609559057862 Date of Registration: 07/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Ziv-aflibercept and Ranibizumab for Macular Edema Secondary to Central Retinal Vein Occlusion
Official scientific title Comparison of Intravitreal Ziv-aflibercept with Ranibizumab for Macular Edema Secondary to Central Retinal Vein Occlusion: A Pilot Randomized Comparative Clinical Trial
Brief summary describing the background and objectives of the trial Macular edema is a major cause of visual impairment in central retinal vein occlusion (CRVO). Intravitreal anti-vascular endothelial growth factor therapy is the standard treatment for CRVO-related macular edema. Ranibizumab has established efficacy in this condition, whereas ziv-aflibercept has been used off-label as a lower-cost anti-VEGF alternative. This prospective randomized comparative interventional study compared the efficacy, safety, and simplified cost-effectiveness based on drug-acquisition cost of intravitreal ziv-aflibercept versus ranibizumab in patients with macular edema secondary to CRVO. Eighteen patients were randomized in a 1:1 ratio to receive either ziv-aflibercept 2 mg/0.08 mL or ranibizumab 0.5 mg/0.05 mL. Both groups received three loading injections at 4-week intervals followed by pro re nata treatment according to optical coherence tomography findings. Patients were followed for 24 weeks. The main outcomes included changes in best-corrected visual acuity and central macular thickness, while secondary outcomes included intraocular pressure, adverse events, reinjection burden, and simplified drug-acquisition cost-effectiveness.
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 01/10/2024
Actual trial start date 15/10/2024
Anticipated date of last follow up 31/08/2025
Actual Last follow-up date 03/09/2025
Anticipated target sample size (number of participants) 18
Actual target sample size (number of participants) 18
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ZUIRB53022SEP2024 Institutional Review Board, Faculty of Medicine, Zagazig University
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 Permuted block randomization Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravitreal Ziv aflibercept 2 mg/0.08 mL intravitreal injection; three loading doses at 4-week intervals, followed by PRN reinjection 24 weeks Participants in Group A received intravitreal ziv-aflibercept at a dose of 2 mg/0.08 mL. Three loading injections were administered at 4-week intervals, followed by pro re nata (PRN) reinjection according to SD-OCT findings. Reinjection criteria included persistent or recurrent intraretinal or subretinal fluid or an increase in central macular thickness of more than 50 µm compared with the previous scan. 9
Control Group Intravitreal Ranibizumab 0.5 mg/0.05 mL intravitreal injection; three loading doses at 4-week intervals, followed by PRN reinjection 24 weeks Participants in Group B received intravitreal ranibizumab at a dose of 0.5 mg/0.05 mL. Three loading injections were administered at 4-week intervals, followed by pro re nata (PRN) reinjection according to SD-OCT findings. Reinjection criteria included persistent or recurrent intraretinal or subretinal fluid or an increase in central macular thickness of more than 50 µm compared with the previous scan. 9 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with ischemic or non-ischemic central retinal vein occlusion (CRVO) with associated macular edema. - CRVO diagnosis and perfusion status were confirmed by fundus fluorescein angiography (FFA). - Central macular thickness (CMT) was at least 400 µm as documented by spectral-domain optical coherence tomography (SD-OCT). - Previous intravitreal anti-VEGF therapy or intravitreal triamcinolone in the study eye within the preceding 3 months. - Coexisting retinal pathology that could affect visual acuity or central macular thickness, including diabetic retinopathy, age-related macular degeneration, or chorioretinitis. - Dense media opacity precluding adequate FFA or OCT imaging. - Inability to complete the scheduled follow-up visits. 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(s) 100 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 22/09/2024 Institutional Review Board Faculty of Medicine Zagazig University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Zagazig University, Zagazig, Sharkia, Egypt Zagazig 44511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in best-corrected visual acuity (BCVA), measured in logMAR, from baseline during follow-up. Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the first intravitreal injection.
Primary Outcome Change in central macular thickness (CMT), measured in micrometers by spectral-domain optical coherence tomography (SD-OCT), from baseline during follow-up. Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the first intravitreal injection.
Secondary Outcome Change in intraocular pressure (IOP), measured in mmHg, from baseline during follow-up. Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks after the first intravitreal injection.
Secondary Outcome Occurrence of ocular, systemic, and injection-related adverse events during the study follow-up period. Throughout the 24-week follow-up period, including post-injection assessments and scheduled follow-up visits.
Secondary Outcome Number of additional intravitreal injections required after completion of the three loading doses. From completion of the loading phase through the end of the 24-week follow-up period.
Secondary Outcome Simplified cost-effectiveness comparison based on drug-acquisition cost, including estimated cost per patient dose and cost in relation to visual and anatomical improvement. At the end of the 24-week follow-up period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ophthalmology Department Zagazig University Hospitals Zagazig University Hospitals, Faculty of Medicine, Zagazig University Zagazig 44511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Abdelrahman Mohamed Mohamed Saber Faculty of Medicine, Zagazig University zagazig 44519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed Abdelrahman Mohamed Mohamed Saber Faculty of Medicine, Zagazig University zagazig 44519 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Saber ahmedasaber62@gmail.com +201211748035 Faculty of Medicine, Zagazig University
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Department of Ophthalmology Faculty of Medicine Zagazig University
Role Name Email Phone Street address
Public Enquiries Ahmed Saber ahmedasaber62@gmail.com +201211748035 Faculty of Medicine Zagazig University
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Department of Ophthalmology Faculty of Medicine Zagazig University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Saber ahmedasaber62@gmail.com +201211748035 Faculty of Medicine Zagazig University
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Department of Ophthalmology Faculty of Medicine Zagazig University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the reported results may be made available upon reasonable request to the Principal Investigator, subject to ethical, institutional, and data-protection requirements. Study Protocol Available after publication of the primary study results and for 5 years thereafter. Access may be granted to researchers submitting a reasonable and scientifically sound request to the Principal Investigator. Only de-identified data will be shared, subject to applicable ethical and institutional requirements.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 25/08/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 25/08/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 20/09/2026 The title was updated to ensure consistency between the clinical trial registry and the corresponding manuscript. This change does not reflect any modification to the study design, interventions, participants, outcomes, or analysis. Comparison of Ziv-aflibercept with Ranibizumab in Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion: A Randomized Clinical Trial Comparison of Intravitreal Ziv-aflibercept with Ranibizumab for Macular Edema Secondary to Central Retinal Vein Occlusion: A Pilot Randomized Comparative Clinical Trial
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 20/09/2026 Reformatted as requested by the reviewer, with each inclusion criterion entered on a separate line. No substantive change was made to the eligibility criteria. Patients with ischemic or non-ischemic central retinal vein occlusion (CRVO) with associated macular edema. CRVO diagnosis and perfusion status were confirmed by fundus fluorescein angiography (FFA). Central macular thickness (CMT) was at least 400 µm as documented by spectral-domain optical coherence tomography (SD-OCT). - Patients with ischemic or non-ischemic central retinal vein occlusion (CRVO) with associated macular edema. - CRVO diagnosis and perfusion status were confirmed by fundus fluorescein angiography (FFA). - Central macular thickness (CMT) was at least 400 µm as documented by spectral-domain optical coherence tomography (SD-OCT).
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 20/09/2026 Reformatted as requested by the reviewer, with each exclusion criterion entered on a separate line. No substantive change was made to the eligibility criteria. Previous intravitreal anti-VEGF therapy or intravitreal triamcinolone in the study eye within the preceding 3 months; coexisting retinal pathology that could affect visual acuity or central macular thickness, including diabetic retinopathy, age-related macular degeneration, or chorioretinitis; dense media opacity precluding adequate FFA or OCT imaging; or inability to complete the scheduled follow-up visits. - Previous intravitreal anti-VEGF therapy or intravitreal triamcinolone in the study eye within the preceding 3 months. - Coexisting retinal pathology that could affect visual acuity or central macular thickness, including diabetic retinopathy, age-related macular degeneration, or chorioretinitis. - Dense media opacity precluding adequate FFA or OCT imaging. - Inability to complete the scheduled follow-up visits.
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 31/08/2026 Updated the source name to the actual name of the Principal Investigator, as requested by the reviewer. The study was self-funded by the Principal Investigator. Self funded by the Principal Investigator, Faculty of Medicine, Zagazig University, zagazig , 44519, Egypt, Self Funded, Ahmed Abdelrahman Mohamed Mohamed Saber, Faculty of Medicine, Zagazig University, zagazig , 44519, Egypt, Self Funded,