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

NCT ID: NCT03458923

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-06-30

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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Diclofenac Sodium 0.1 ml containing 500µg

Intervention Type: DRUG

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

Group B

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

Group Type: ACTIVE_COMPARATOR

Ranibizumab 0.5 mg Solution for Injection

Intervention Type: DRUG

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

Interventions

Diclofenac Sodium 0.1 ml containing 500µg

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

Intervention Type: DRUG

Ranibizumab 0.5 mg Solution for Injection

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

Intervention Type: DRUG

Other Intervention Names

nonsteroidal anti-inflammatory drug; anti vascular endothelial growth factor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Iyad Adnan Salem Goussous

Doctor Iyad Adnan Salem Goussous

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed S El Agha, PhD

Role: STUDY_CHAIR

Cairo University

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Iyad A Goussous, MSc

Role: CONTACT

dr.iyad.goussous@hotmail.com

00201062453343

Facility Contacts

Mohamed S El Agha, PhD

Role: primary

mselagha@hotmail.com

00201001638180

Other Identifiers

Iyad Goussous

Identifier Type: -

Identifier Source: org_study_id