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.: PACTR202509763211872 Date of Registration: 11/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Safety and efficacy of subconjunctival bevacizumab compared with placebo in the management of acquired cornea opacity with neovascularization.
Official scientific title Safety and efficacy of subconjunctival bevacizumab compared with placebo in the management of acquired cornea opacity with neovascularization.
Brief summary describing the background and objectives of the trial This trial is about the safety and efficacy of 5.0mg/0.02ml of subconjunctival bevacizumab compared with placebo in the management of corneal opacity with neovascularization of various etiologies. Blinding corneal opacity is one of the major causes of severe visual impairment globally and an important treatment modality for this ocular pathology is penetrating keratopathy with high cost and less accessibility in the management of corneal opacity in some African countries. Hence the need to explore other safe, efficient, affordable and accessible options with trial of subconjunctival bevacizumab. Trial objectives includes: 1. To describe the clinical characteristics and risk factors of patients with acquired corneal opacity with neovascularization recruited for the study. 2. To determine and compare the clinical characteristics of the acquired corneal opacity with neovascularization between patients who had subconjunctival bevacizumab injection and those on placebo. 3. To measure and compare the visual acuity outcomes between between patients who had subconjunctival bevacizumab injection and those on placebo. 4. To measure and compare the degree of functional impairment and its effect on activities of daily living and quality of life using National Eye Institute, Visual Function Questionnaire ( NEI-VFQ 25 ) among patients with acquired corneal opacity receiving subconjunctival bevacizumab and those who had placebo.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT Randomized Controlled Trial
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 01/10/2025
Actual trial start date 01/10/2025
Anticipated date of last follow up 01/10/2026
Actual Last follow-up date 01/10/2026
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants) 64
Recruitment status Not yet recruiting
Publication URL www.lasuth.org.ng
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group subconjunctival bevacizumab 5.0mg in 0.02ml,to be given twice. At baseline and 4weeks after. Bevacizumab is an anti VEGF which is a full-length recombinant, humanized, monoclonal immunoglobin GI ( IgGI ) antibody, ( 93% human, 7% murine sequences – molecular weight 149kDa ) produced by DNA technology. Bevacizumab binds to VEGF A and prevents endothelial cell differentiation, proliferation, migration, and inhibits resultant angiogenesis. It has greater effects on new, active, immature vessels than old stable vessels by occluding the former. It’s a clear colorless to pale brown solution with pH of 6.2, which comes in 4ml or 16ml vials with a concentrations of 25mg/ml. It is been used widely for the treatment of oncological pathologies like colorectal cancer, lung cancers and brain cancer in dosages of 5-15mg/kg IV q2-3Weeks, and it’s the first approved angiogenesis inhibitor. 32
Control Group Sterile water for injection 0.02ml To be given at baseline and 4weeks after The placebo for comparison in this study will be sterile water for injection ( WFI ) in a dose of 0.2mls subconjunctival injection. WFI is a specially prepared non-pyogenic, highly purified form of water and pharmaceutically inert liquid used commonly as a diluent to dissolve other medications and for intramuscular or intravenous injection preparation. It is also used in inhalation treatment to deliver medications to the lungs. It has been safely used as placebo via topical, subcutaneous and subconjunctival routes in randomized controlled trials and double-blind studies. Although pain or discomfort at the site of injection has been reported but it’s been largely considered generally safe and efficient in comparing the effect of a real drug against no treatment. 32 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients who give their consents. 2. Patients with grade 2 and 3 corneal opacity, with associated neovascularization grade 2 to 4 who present to the eye clinic of LASUTH within the period of study. 3. Age-18 years ( legal age for consent in Nigeria ) to 80 years. 4. Patients not on any anti VEGF therapy in the previous one month. 1. Patients younger than 18yrs. 2. Patients with an active ocular inflammation or infection. 3. Patients with visual impairment from other causes like cataract, uncontrolled glaucoma and macular disorders. 4. Patient with no light perception in the eye for study. 5. Patient with an only eye. 6. Patients with an uncontrolled hypertension and other contraindications to bevacizumab like cardiac diseases, renal failure and gastrointestinal perforations. 7. Pregnant and lactating mothers. Adolescent: 13 Year-18 Year,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 19/08/2025 National Health Research Ethics Committee. NHREC Nigeria
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi way Ikeja Lagos Lagos 110011 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures will be: 1.The number of corneal surface segment covered by opacity using digital pictures with a specially made computer-generated pattern of segments which is to be fitted over the digital corneal photograph taken for the estimation. And 2. The number of corneal surface segments with corneal neovascularization. Before the onset of interventions and after.
Secondary Outcome Secondary outcome measures will be: 1.The best corrected visual acuity. 2.complications related to the interventions and 3.participants’ quality of life changes. Before the onset of intervention and after.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Eye clinic Lagos State University Teaching Hospital LASUTH. Ikeja 1-5 Oba Akinjobi way. Ikeja-Lagos Ikeja 110011 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Abe Adeola 1-5 Oba Akinjobi way, Ikeja Lagos Lagos 110011 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abe Adeola 1-5 Oba Akinjobi way, Ikeja Lagos Lagos 110011 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adeola Abe abe.adeola@yahoo.com +2349060203510 1-5 Oba Akinjobi Way, Ikeja Lagos
City Postal code Country Position/Affiliation
Lagos 110011 Nigeria Senior Registrar Department of Ophthalmology LASUTH
Role Name Email Phone Street address
Public Enquiries Sedoten Bashorun sedoten_12@yahoo.com +23423688141 1-5 Oba Akinjobi Way, Ikeja Lagos
City Postal code Country Position/Affiliation
Lagos 110011 Nigeria Consultant Department of Ophthalmology LASUTH
Role Name Email Phone Street address
Scientific Enquiries Bola Adekoya bjadekoya2007@yahoo.com +2348033817215 1-5 Oba Akinjobi Way, Ikeja Lagos
City Postal code Country Position/Affiliation
Lagos 110011 Nigeria Head of Department eye clinic LASUTH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All information collected from individual trial participant in this study will be given code numbers, and no name or personal identifiers will be recorded. This information will be routinely available to me: the principal investigator and my immediate supervisors. Authorized representatives of the ethics committee or the hospital regulatory board may inspect individual trial participant records available to me for monitoring and auditing. Informed Consent Form Immediately following publication. No end date. Data will be made available to relevant bodies or individuals for pertinent purposes.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.lasuth.gov.ng 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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 05/09/2025 18 years is considered the minimum age of majority for legal matters in Nigeria including consent for research. 1. Patients younger than 19yrs. 2. Patients with an active ocular inflammation or infection. 3. Patients with visual impairment from other causes like cataract, uncontrolled glaucoma and macular disorders. 4. Patient with no light perception in the eye for study. 5. Patient with an only eye. 6. Patients with an uncontrolled hypertension and other contraindications to bevacizumab like cardiac diseases, renal failure and gastrointestinal perforations. 7. Pregnant and lactating mothers. 1. Patients younger than 18yrs. 2. Patients with an active ocular inflammation or infection. 3. Patients with visual impairment from other causes like cataract, uncontrolled glaucoma and macular disorders. 4. Patient with no light perception in the eye for study. 5. Patient with an only eye. 6. Patients with an uncontrolled hypertension and other contraindications to bevacizumab like cardiac diseases, renal failure and gastrointestinal perforations. 7. Pregnant and lactating mothers.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 11/09/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 05/09/2025 Better understanding of questions This trial compares the safety and efficacy of subconjunctival bevacizumab with placebo in the management of acquired corneal opacity with neovascularization as an adjuvant or stand alone treatment. Forth-four consenting Participants who meet up with inclusion criteria will be consecutively chosen from LASUTH eye clinic out-patients and enrolled by simple randomization into treatment and control group. Treatment will be initiated at baseline and four weeks after. Data collected will be analyzed for changes in pathology before and after intervention, then control group will be equally treated after the conclusion of the study. All information collected from individual trial participant in this study will be given code numbers, and no name or personal identifiers will be recorded. This information will be routinely available to me: the principal investigator and my immediate supervisors. Authorized representatives of the ethics committee or the hospital regulatory board may inspect individual trial participant records available to me for monitoring and auditing.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 05/09/2025 Better understanding of questions 1 year Immediately following publication. No end date.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 05/09/2025 Better understanding of questions 1. Could subconjunctival bevacizumab injection reduce corneal area covered by opacities with its associated neovascularization in a hospital based Nigerian population ? 2. Could subconjunctival bevacizumab injection improve patient’s best corrected visual acuity in a hospital based Nigerian population ? 3. What are the side effects of subconjunctival bevacizumab injection ? 4. Does subconjunctival bevacizumab 5.0mg/0.2ml give same outcome as 0.2ml of subconjunctival sterile water in a hospital based Nigerian population ? 5. What is the effect of ACONV on quality of life and daily living activities of patients attending LASUTH eye clinic before receiving subconjunctival bevacizumab and after the intervention? Data will be made available to relevant bodies or individuals for pertinent purposes.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 05/09/2025 Better understanding of questions www.lasuth.gov.ng
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 05/09/2025 Better understanding of questions Informed Consent Form, Clinical Study Report Informed Consent Form
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 05/09/2025 18 years is considered the minimum age of majority for legal matters in Nigeria including consent for research. 19 Year(s) 18 Year(s)