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.: PACTR202204601902304 Date of Approval: 14/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intravitreal injection versus medical treatment for acute CSR
Official scientific title Evaluation of the Effect of Intravitreal Anti-vascular Endothelial Growth Factor versus Medical Treatment in Acute Central Serous Chorioretinopathy
Brief summary describing the background and objectives of the trial Central serous chorioretinopathy (CSCR) is a condition occurring in young adults, especially males in their twenties to fifties, who exhibit acute or subacute central visual loss or distortion. It is an idiopathic disorder characterized by a localized serous detachment of the sensory retina at the macula secondary to leakage from the choriocapillaris in association with retinal pigment dysfunction. Different treatment options are available including observation, photodynamic therapy, laser photocoagulation, micropulse diode laser and intravitreal anti VEGF agents. So, this study is designed to evaluate the efficacy and safety of intravitreal ranibizumab or aflibercept versus medical therapy with oral spironolactone for treatment of patients with acute central serous chorioretinopathy.
Type of trial CCT
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 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 30/04/2022
Actual Last follow-up date 15/05/2022
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Oral spironolactone 100 mg once daily 6 weeks Oral medical treatment 15 Active-Treatment of Control Group
Experimental Group Intravitreal injection of Ranibizumab 0.5 mg Single injection Intravitreal injection 15
Experimental Group Intravitreal injection of Aflibercept 2 mg Single injection Intravitreal injection 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients older than 18 years old, with presence of serous detachment of neurosensory retina on optical coherence tomography angiography (OCTA), evidence of fluorescent leakage on fundus fluorescein angiography (FFA) and symptom duration less than 3 months will be enrolled in the study. Patients with chronic CSCR, secondary choroidal neovascularization, other eye diseases such as AMD, polypoidal choroidal vasculopathy, glaucoma, or ocular trauma; or having history of systemic steroid usage before the onset of the clinical symptoms will be excluded from the study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 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 27/03/2022 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
Kilo 4.5 Ring Road Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Visual recovery Baseline and then monthly over duration of 6 months
Secondary Outcome Central macular thickness, central choroidal thickness, vascular density, pattern on flourescein angiography and duration of visual recovery At baseline and then monthly over duration of 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospital Kilo 4.5 Ring Road Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moataz A. Sallam Building no.42 - El-Sheikh Zayed district - Romani theatre Land - 5th stage Ismailia 41112 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Hospital Kilo 4.4 Ring Road Ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moataz Sallam moataz.sallam@med.suez.edu.eg +201111113588 Romani theatre land, 5th Stage, El-Sheikh Zayed district, building no. 42, flat no. 5
City Postal code Country Position/Affiliation
Ismailia 41112 Egypt Lecturer at Faculty of Medicine Suez Canal University
Role Name Email Phone Street address
Public Enquiries Moataz Sallam Moataz.sallam@med.suez.edu.eg +201111113588 Romani theatre land, 5th Stage, El-Sheikh Zayed district, building no. 42, flat no. 5
City Postal code Country Position/Affiliation
Ismailia 41112 Egypt Lecturer at Faculty of Medicine Suez Canal University
Role Name Email Phone Street address
Scientific Enquiries Moataz Sallam moataz.sallam@med.suez.edu.eg +201111113588 Romani theatre land, 5th Stage, El-Sheikh Zayed district, building no. 42, flat no. 5
City Postal code Country Position/Affiliation
Ismailia 41112 Egypt Lecturer at Faculty of Medicine Suez Canal University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available 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