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| ID | Type | Description | Link |
|---|---|---|---|
| NEPAFENACO |
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The purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy.
Objective: To evaluate the effect of topical nepafenac 0.1 %, in preventing and in treating macular thickening related to pan-retinal photocoagulation in diabetic patients. Material and methods: This is a prospective, longitudinal, and controlled study in patients with diabetic retinopathy (severe non-proliferative and proliferative retinopathy), with a symmetric severity in both eyes and without a clinical significant macular edema. The best corrected visual acuity (BCVA) in all patients was 20/80 or better. All patients will undergo pan-retinal photocoagulation in three different sessions (with 2 weeks in apart between them). Each patient will receive topical nepafenac 0.1% (qid) on one eye, and placebo (qid) at the fellow eye, starting 1 week before the first retinal photocoagulation session and continued for 9 weeks ( ending 4 weeks after pan-retinal photocoagulation is completed). Spectral domain OCT and BCVA in ETDRS scale will be performed before and at 2 weeks after each laser session, and at 1, 2 and 3 months after treatment completed. BCVA and OCT outcomes of each studied period will be compared on both eyes, and side effects will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Nepafenac | Active Comparator | Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed. |
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| 2: placebo | Placebo Comparator | Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepafenac | Drug | Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed. |
| Measure | Description | Time Frame |
|---|---|---|
| Central macular thickening | 2 weeks after each laser session and 1 and 2 months after last laser session |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | 2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dulce O Rascon-Vargas, Fellow | Asociación Para Evitar la Ceguera en México I.A.P. | Principal Investigator |
| Guadalupe Cervantes-Coste | Asociación Para Evitar la Ceguera en México I.A.P. | Study Chair |
| Jans Fromow-Guerra | Asociación Para Evitar la Ceguera en México I.A.P. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Para Evitar la Ceguera en México I.A.P. | Mexico City | 004030 | Mexico | |||
| Asociacion para Evitar la Ceguera en Mexico I.A.P. |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C414203 | nepafenac |
| D054327 | Lubricants |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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| Lubricant | Other | Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed |
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| Mexico City |
| 04030 |
| Mexico |