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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 15 eyes will receive 0.1 ml containing 500µg of diclofenac intravitreally, repeated monthly for 3 months. |
|
| Group B | Active Comparator | 15 eyes will receive 0.5 mg Ranibizumab intravitreally, repeated monthly for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iyad A Goussous, MSc | Contact | 00201062453343 | dr.iyad.goussous@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed S El Agha, PhD | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D000069579 | Ranibizumab |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ranibizumab 0.5 mg Solution for Injection | Drug | 15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months |
|
|
| D018712 |
| Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |