Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema
NCT ID: NCT03975088
Last Updated: 2019-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2017-01-01
2018-12-31
Brief Summary
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Detailed Description
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Methods: This is a prospective interventional non-comparative study including patients with refractory DME. Included patients were subjected to the new surgical technique of pars plana vitrectomy with sub-retinal injection of Ranibizumab.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Persistent Diabetic macular edema
Authors defined refractory DME as eyes with persistent DME despite receiving at least 6 monthly Ranibizumab injections of anti VEGF, and then switched to Aflibercept, receiving at least three monthly injections.
Sub-macular injection of Ranibizumab
In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
Interventions
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Sub-macular injection of Ranibizumab
In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
Eligibility Criteria
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Inclusion Criteria
* Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy.
* Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5.
Exclusion Criteria
* evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT,
* glaucoma and one eyed patients.
18 Years
ALL
No
Sponsors
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University of Alexandria
OTHER
Responsible Party
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Mahmoud Abouhussein
Assistant professor
References
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El-Baha SM, Abdel Hadi AM, Abouhussein MA. Submacular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema. J Ophthalmol. 2019 Oct 21;2019:6274209. doi: 10.1155/2019/6274209. eCollection 2019.
Other Identifiers
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31185
Identifier Type: -
Identifier Source: org_study_id
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