Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
Primary Purpose
Diabetic Macular Edema
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Diclofenac Sodium 0.1 ml containing 500µg
Ranibizumab 0.5 mg Solution for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diclofenac, Ranibizumab, Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Diabetic retinopathy with non tractional maculopathy, where central macular thickness is greater than 400µm, with and without cystic changes.
- Diabetes Mellitus type one and two
- Best Corrected Visual Acuity > 0.1 LogMar
Exclusion Criteria:
- Patients treated with diclofenac, Ranibizumab or Bevacizumab in the past 3 months
- Patients with a history of branch or central retinal artery occlusion
- Patients without clear media and adequate pupillary dilation that allows proper fundoscopy and imaging, and patients who are not complaint with the regular visits.
- Visual Significant Cataract
- Evidence of vitreomacular traction or macular ischemia
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months.
15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months.
Outcomes
Primary Outcome Measures
Change in best corrected visual acuity
Measuring the best corrected visual acuity
Change in central macular thickness
Measuring the change in central macular thickness using Optical Coherence Tomography
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03458923
Brief Title
Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
Official Title
Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The study aims to compare the effect of intravitreal non steroidal anti inflammatory (Diclofenac) versus the standard treatment of diabetic macular edema, intravitreal anti vascular endothelial growth factor (Ranibizumab), measuring central macular thickness changes and best corrected visual acuity.
Detailed Description
Thirty eyes of diabetic patients with diabetic retinopathy with macular edema will be randomized using simple randomization method into two groups; A and B.
Group A will undergo intravitreal injection of 500µg Diclofenac, repeated monthly for 3 months. Electroretinogram will be performed before the injections, 4 weeks after first injection and 4 weeks after third injection to assess any risk of toxicity.
Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.
Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.
Visual acuity will be assessed before and after each injection.
Group B will undergo intravitreal injection of 0.5 mg Ranibizumab, repeated monthly for 3 months. Colored photography and fundus fluorescein angiography will be done before the first injection to assess the extent of macular leakage at late phases, and to exclude cases with macular ischemia.
Optical coherence tomography will be done to measure the central macular thickness, before the first injection, and before each injection.
Visual acuity will be assessed before and after each injection.
All patients will be examined weekly for one month and then monthly for three months after the injection. At every visit, visual acuity, intraocular pressure, and a dilated fundus examination will be performed.
All patients will be required to instill topical antibiotic Gatifloxacin postoperatively 3 times per day for 5 days.
Patients will be warned about the signs and symptoms of complications (endophthalmitis, retinal detachment, vitreous hemorrhage, lens trauma) and asked to seek medical attention immediately.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diclofenac, Ranibizumab, Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months.
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium 0.1 ml containing 500µg
Other Intervention Name(s)
nonsteroidal anti-inflammatory drug
Intervention Description
15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5 mg Solution for Injection
Other Intervention Name(s)
anti vascular endothelial growth factor
Intervention Description
15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months
Primary Outcome Measure Information:
Title
Change in best corrected visual acuity
Description
Measuring the best corrected visual acuity
Time Frame
3 months of follow up
Title
Change in central macular thickness
Description
Measuring the change in central macular thickness using Optical Coherence Tomography
Time Frame
3 months of follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic retinopathy with non tractional maculopathy, where central macular thickness is greater than 400µm, with and without cystic changes.
Diabetes Mellitus type one and two
Best Corrected Visual Acuity > 0.1 LogMar
Exclusion Criteria:
Patients treated with diclofenac, Ranibizumab or Bevacizumab in the past 3 months
Patients with a history of branch or central retinal artery occlusion
Patients without clear media and adequate pupillary dilation that allows proper fundoscopy and imaging, and patients who are not complaint with the regular visits.
Visual Significant Cataract
Evidence of vitreomacular traction or macular ischemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iyad A Goussous, MSc
Phone
00201062453343
Email
dr.iyad.goussous@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S El Agha, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed S El Agha, PhD
Phone
00201001638180
Email
mselagha@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
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