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.: PACTR201705002168252 Date of Approval: 03/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Which Is First Argon Laser Therapy Or Intravitreal Bivacizumab In Branch Retinal Vein Occlusion With Macular Oedema.
Official scientific title Which Is First Argon Laser Therapy Or Intravitreal Bivacizumab In Branch Retinal Vein Occlusion With Macular Oedema.
Brief summary describing the background and objectives of the trial To compare anatomical and functional efficacy of argon laser therapy followed by intravitreal bivacizumab with intravitreal bevacizumab firstly followed by argon laser therapy for macular edema due to branch retinal vein occlusion (BRVO).
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Macular edema, branch retinal vein occlusion
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/09/2016
Actual trial start date 05/10/2016
Anticipated date of last follow up 10/05/2017
Actual Last follow-up date 12/07/2017
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
Recruitment status Completed
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group argon macular grid laser followed by intravitreal bivacizumab one argon macular grid laser 25 Active-Treatment of Control Group
Control Group intravitreal bivacizumab followed by argon macular grid laser one intravitreal bivacizumab 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with macular edema secondary to branch retinal vein occlusion The patients who had coexisting retinal disease (like diabetic retinopathy and epiretinal membrane); media opacities that could decrease visual acuity, or macular ischemia, concurrent ocular in¿ammation or infection, intraocular surgery (including post vitrectomized eyes) within the previous 3 months, patients of incomplete follow up 45 Year(s) 65 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
No 03/07/2017 Sohag faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Al Mohafaza,Street Sohag 82511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Best corrected visual effect before after 1 month after 3 month after 6 month
Secondary Outcome central foveal thickness before intervension after first month after 3 month after 6 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospital, Al Mohafaza, street Sohag 82511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ophthalmology department Almohafaza, street Sohag 82511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ophthalmology department Almohafaza, street Sohag 82511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Amr Mounir Al Gomhoria, street Sohag 82511 Egypt
Alahmady Hamad Al Gomhoria, street Sohag 82511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amr Mounir dramrmonir@yahoo.com 00201005026170 Al Gomhoria, street
City Postal code Country Position/Affiliation
Sohag 82511 Egypt
Role Name Email Phone Street address
Public Enquiries Ahmad Moustafa amoustafa77@hotmail.com 00201023092323 Sohag,Assuit street
City Postal code Country Position/Affiliation
Sohag 82511 Egypt
Role Name Email Phone Street address
Scientific Enquiries Alahmady Hamad alahmady20@yahoo.com 0020111102698 Al Gomhoria, street
City Postal code Country Position/Affiliation
Sohag 82511 Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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