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.: PACTR202206535473146 Date of Approval: 21/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of optic nerve perfusion after pan retinal photocoagulation (PRP) versus anti vascular endothelial growth factor (antiVEGF) injection for treatment of high risk proliferative diabetic retinopathy(PDR)
Official scientific title Comparison of optic nerve perfusion after pan retinal photocoagulation (PRP) versus anti vascular endothelial growth factor (antiVEGF) injection for treatment of high risk proliferative diabetic retinopathy (PDR)
Brief summary describing the background and objectives of the trial PRP has been the standered treatment to PDR but it has many complications , many studies observed a great effect of intravitreal anti VEGF injection in PDR we aim to measure the effect of PRP versus intravitreal anti VEGF injection (Ranizumab) on peri papillary vascular density (indicator to optic nerve ischemia ) using OCT angiography in high risk PDR patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 21/07/2019
Actual trial start date 21/07/2019
Anticipated date of last follow up 01/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Closed to recruitment,follow-up continuing
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intravitreal anti VEGF Ranizumab Ranizumab 0.3 mg /0.05 ml monthly injection for 3 consecutive months monthly for 3 months intravitreal Ranizumab 0.3mg/0.05 ml monthly injection for 3 months, 3.5 and 4 mm from limbus according patient is pseudophake or phakic and paracentesis is done if oculer tension elevated and vision dropped to no perception of light , follow up next day for any complication then injection continued monthly for 3 months 25
Control Group panretinal photocoagulation PRP from 1600 to 2000 pulses , divided into 2 sessions within 1 week 2 sessions within a week then follow up monthly for 3 months PRP was done into 2 sesssions ,1600 to 2000 pulses , 2 disc diameter from limbus and 3 disc diameter from fovea outside vasculer archades , power is adjusted to do just grayish spot , spot size 200 micron , duration 100 msec 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 Naive high risk PDR (neovascularization on disc (NVD) more than 1/3 disc area or any NVD with vitreous hemorrhage)  clear media  patients with media opacity  other retinal and optic nerve diseases rather than diabetic retinopathy  anti VEGF or steroid intravitreal injection  previous PRP  tractional retinal detachment  glaucoma or any form of optic neuropathy Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 21/07/2019 Ain Shams university Faculty of medicine Research ethics committee
Ethics Committee Address
Street address City Postal code Country
56 Ramses street , el Abassia cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparing peri papillary vascular density after PRP and anti VEGF (Ranizumab) OCT angiography is done before intervention and monthly for 3 months
Secondary Outcome 1. Visual field change (mean deviation and pattern standard deviation) 2. macular capillary density 3. visual acuity 4. Neovascular area on disc (NVD area) if possible visual field before intervention and 3 months after intervention , visual acuity , maculer density and NVD area are measured before intervention and monthly for 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospital 56 Ramses street , El Abassia cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain shams university hospital Ramses street , Elabassia cairo 11588 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain shams university hospital 56, Ramses street , Elabbasia cairo 11566 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed magdy Raafat building 60, High town compound Giza 12573 Egypt
mohammed ahmad Rashad Ramses street , elabassia cairo 11588 Egypt
Rania gamal eldin Zaki Ramses street , elabbasia cairo 11588 Egypt
Hesham mohamed Gharieb Ramses street , elabassia cairo 11588 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ahmed Mohammadahmadrashadeyelaser@gmail.com 01115758888 56 Ramses sreet , Elabbasia
City Postal code Country Position/Affiliation
caro 11566 Egypt professor ophtalmology faculty of medicine Ain shams university
Role Name Email Phone Street address
Scientific Enquiries Rania Gamal dr.raniazaki@hotmail.com 01006229005 56 Ramses street , Elabbasia
City Postal code Country Position/Affiliation
cairo 11566 Egypt Assistant professor of ophthalmology Ain shams university
Role Name Email Phone Street address
Public Enquiries Hesham Mohamed h_gharieb@med.asu.edu.eg 01000673215 56 Ramses street ,El abbassia
City Postal code Country Position/Affiliation
cairo 11566 Egypt teacher of ophthalmology faculty of medicine Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all data will be available and sent to researchers upon request from principal investigator Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol the data will be available immediatly following publication with no end date all data will be available and sent to researchers upon request from principal investigator
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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