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

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ClinicalTrials.gov Identifier: NCT03458923
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Iyad Adnan Salem Goussous, Cairo University

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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 Name: 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 Name: anti vascular endothelial growth factor




Primary Outcome Measures :
  1. Change in best corrected visual acuity [ Time Frame: 3 months of follow up ]
    Measuring the best corrected visual acuity

  2. Change in central macular thickness [ Time Frame: 3 months of follow up ]
    Measuring the change in central macular thickness using Optical Coherence Tomography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458923


Contacts
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Contact: Iyad A Goussous, MSc 00201062453343 dr.iyad.goussous@hotmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: Mohamed S El Agha, PhD    00201001638180    mselagha@hotmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Mohamed S El Agha, PhD Cairo University

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Responsible Party: Iyad Adnan Salem Goussous, Doctor Iyad Adnan Salem Goussous, Cairo University
ClinicalTrials.gov Identifier: NCT03458923     History of Changes
Other Study ID Numbers: Iyad Goussous
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Iyad Adnan Salem Goussous, Cairo University:
Diclofenac
Ranibizumab
Diabetic Macular Edema
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diclofenac
Ranibizumab
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action