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| Sponsor: | Asociación para Evitar la Ceguera en México |
|---|---|
| Information provided by: | Asociación para Evitar la Ceguera en México |
| ClinicalTrials.gov Identifier: | NCT00801905 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Thickening Macular Edema |
Drug: Nepafenac Other: Lubricant |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation |
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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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Drug: Nepafenac
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.
|
|
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
|
Other: Lubricant
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dulce O Rascon-Vargas, Fellow | (52) 55 10841400 ext 1167 | dorv_md@hotmail.com |
| Mexico | |
| Asociación Para Evitar la Ceguera en México I.A.P. | Recruiting |
| Mexico City, Mexico, 004030 | |
| Contact: Dulce O Rascon-Vargas, Fellow (52) 55 10841400 ext 1167 dorv_md@hotmail.com | |
| Asociacion para Evitar la Ceguera en Mexico I.A.P. | Recruiting |
| Mexico City, Mexico, 04030 | |
| Contact: Guadalupe Cervantes-Coste (52) 55 10841400 ext 1167 gpecervantes@hotmail.com | |
| Contact: Jans Fromow-Guerra (52) 55 10841400 ext 1167 fromow@servidor.unam.mx | |
| Principal Investigator: | Dulce O Rascon-Vargas, Fellow | Asociación Para Evitar la Ceguera en México I.A.P. |
| Study Chair: | Guadalupe Cervantes-Coste | Asociación Para Evitar la Ceguera en México I.A.P. |
| Study Director: | Jans Fromow-Guerra | Asociación Para Evitar la Ceguera en México I.A.P. |
More Information
| Responsible Party: | Asociación Para Evitar la Ceguera en México I.A.P. ( Dulce Oliva Rascon-Vargas ) |
| Study ID Numbers: | NEPAFENAC IN PRFC, NEPAFENACO |
| Study First Received: | December 3, 2008 |
| Last Updated: | December 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00801905 History of Changes |
| Health Authority: | Mexico: Ethics Committee |
|
Macular thickening Macular edema Pan-retinal photocoagulation Nepafenac Topical non-steroidal anti inflammatory agents |
|
Anti-Inflammatory Agents Eye Diseases Physiological Effects of Drugs Edema Macular Degeneration Retinal Degeneration Pharmacologic Actions Macular Edema Signs and Symptoms |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Retinal Diseases |