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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201701001940111 |
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Date of registration:
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25/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety of ziv-aflibercept in retinal diseases in a Ghanaian population.
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Scientific title:
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Safety of ziv-aflibercept in retinal diseases in a Ghanaian population. |
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Date of first enrolment:
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01/02/2017 |
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Target sample size:
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20 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1940 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,picking 2 labelled cards from an envelope by an individual independent of the study investigators (EA) but the treatment is concealed to the patients.A certified physician (unmasked) will give the intravitreal injection. The examining physician(IZB) and an independent assessor of anatomic response(WMA) will be masked to the treatment doses.,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Benjamin
Abaidoo |
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Address:
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Department of surgery (Eye), School of Medicine and Dentistry, University of Ghana
4236
Accra
Ghana |
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Telephone:
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+233 27 781 8746 |
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Email:
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benjamin_abaidoo@yahoo.com |
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Affiliation:
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Senior research Assistant, School of Medicine and Dentistry, University of Ghana. |
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Name:
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Imoro Zeba
Braimah |
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Address:
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Alexander St, Block 3B, Drs Flats, Korle-Bu
4236
Accra
Ghana |
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Telephone:
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+233206301353 |
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Email:
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zebaimoro2000@yahoo.com |
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Affiliation:
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Lecturer School Medicine Dentistry; Consul Ophthalmologist Korle-Bu Teaching Hosp |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age 18 years or older
Meets diagnostic criteria for DM, RVO and active nvAMD (Appendix I)
Treatment naïve
Understands and willing to sign consent form
Able to comply with clinic visits
Centre involving ME in patients with diabetes mellitus and RVO with retinal thickness >300um using SD- OCT
BCVA of 6/12 or worse
Exclusion criteria: Glaucoma or raised intraocular pressure (>21mmHg)
Intraocular surgery within 3 months in the study eye
History of uveitis
Pregnant or breastfeeding mother
Renal failure on dialysis or had kidney transplant
Allergy to active drug or excipients
Cardiovascular events such as myocardial infarction or CVA
Eye infections such blepharitis, dacryocystitis, conjunctivitis or keratitis.
Unwilling to sign consent form or to come for follow up visits
Myopia ¿-6.0 Dioptres
Age minimum:
18 Year(s)
Age maximum:
85 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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diabetic macula edema,
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Eye Diseases
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Eye Diseases
diabetic macula edema,
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Intervention(s)
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intravitreal ziv-aflibercept
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intravitreal ziv-aflibercept 1.25mg
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Primary Outcome(s)
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safety of intravitreal ziv-aflibercept includingincidence of raised intraocular pressure, cataract progression, intraocular inflammation and endophthalmitis
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Secondary Outcome(s)
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ocular and systemic safety parameters, change in BCVA (ETDRS letters), central subfield foveal thickness (CSFT) and central retinal thickness (CRT) using SD-OCT
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Source(s) of Monetary Support
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Eye Centre Korle-Bu Teaching Hospital
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Ethics review
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Status: Not approved
Approval date:
Contact:
Scientific and Technical Committee of Korle-Bu Teaching Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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