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

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Drug: Diclofenac Sodium 0.1 ml containing 500µg; Drug: Ranibizumab 0.5 mg Solution for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03458923

Iyad Goussous

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group A

Active Comparator group

Description:

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

Treatment:

Drug: Diclofenac Sodium 0.1 ml containing 500µg

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Ranibizumab 0.5 mg Solution for Injection