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

NCT03458923 | Unknown Phase 4

• 1 other identifier: Iyad Goussous
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

Diclofenac; Ranibizumab; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• Change in best corrected visual acuity

  Measuring the best corrected visual acuity

  3 months of follow up

• Change in central macular thickness

  Measuring the change in central macular thickness using Optical Coherence Tomography

  3 months of follow up

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Drug: Ranibizumab 0.5 mg Solution for Injection

Interventions

Diclofenac Sodium 0.1 ml containing 500µg DRUG

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

Also known as: nonsteroidal anti-inflammatory drug

Group A

Ranibizumab 0.5 mg Solution for Injection DRUG

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

Also known as: anti vascular endothelial growth factor

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Ranibizumab; Solutions; Injections

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mohamed S El Agha, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Iyad A Goussous, MSc

CONTACT

00201062453343; dr.iyad.goussous@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Iyad Adnan Salem Goussous

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 8, 2018
• Study Start: January 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

EG (1)