Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03458923

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Diclofenac Sodium 0.1 ml containing 500µg Drug: Ranibizumab 0.5 mg Solution for Injection	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.

Actual Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A 15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months.	Drug: Diclofenac Sodium 0.1 ml containing 500µg 15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months Other Names: nonsteroidal anti-inflammatory drug
Active Comparator: Group B 15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months.	Drug: Ranibizumab 0.5 mg Solution for Injection 15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months Other Names: anti vascular endothelial growth factor

Arm

Intervention/Treatment

Active Comparator: Group A

15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months.

Drug: Diclofenac Sodium 0.1 ml containing 500µg

15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months

Other Names:

nonsteroidal anti-inflammatory drug

Active Comparator: Group B

15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months.

Drug: Ranibizumab 0.5 mg Solution for Injection

15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months

Other Names:

anti vascular endothelial growth factor

Outcome Measures

Primary Outcome Measures

Change in best corrected visual acuity [3 months of follow up]
Measuring the best corrected visual acuity
Change in central macular thickness [3 months of follow up]
Measuring the change in central macular thickness using Optical Coherence Tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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