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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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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03458923 |
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Date of registration:
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26/02/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
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Scientific title:
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Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema. |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03458923 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Iyad A Goussous, MSc |
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Address:
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Telephone:
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00201062453343 |
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Email:
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dr.iyad.goussous@hotmail.com |
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Affiliation:
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Name:
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Mohamed S El Agha, PhD |
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Address:
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Telephone:
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00201001638180 |
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Email:
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mselagha@hotmail.com |
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Affiliation:
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Name:
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Mohamed S El Agha, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diabetic retinopathy with non tractional maculopathy, where central macular thickness
is greater than 400µm, with and without cystic changes.
2. Diabetes Mellitus type one and two
3. Best Corrected Visual Acuity > 0.1 LogMar
Exclusion Criteria:
1. Patients treated with diclofenac, Ranibizumab or Bevacizumab in the past 3 months
2. Patients with a history of branch or central retinal artery occlusion
3. Patients without clear media and adequate pupillary dilation that allows proper
fundoscopy and imaging, and patients who are not complaint with the regular visits.
4. Visual Significant Cataract
5. Evidence of vitreomacular traction or macular ischemia
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetic Macular Edema
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Intervention(s)
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Drug: Diclofenac Sodium 0.1 ml containing 500µg
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Drug: Ranibizumab 0.5 mg Solution for Injection
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Primary Outcome(s)
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Change in best corrected visual acuity
[Time Frame: 3 months of follow up]
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Change in central macular thickness
[Time Frame: 3 months of follow up]
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Secondary ID(s)
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Iyad Goussous
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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