Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation (NEPAF)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Asociación para Evitar la Ceguera en México.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Asociación para Evitar la Ceguera en México
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00801905
First received: December 3, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation |
Resource links provided by NLM:
Genetics Home Reference related topics:
age-related macular degeneration
X-linked juvenile retinoschisis
MedlinePlus related topics:
Edema
Drug Information available for:
Nepafenac
U.S. FDA Resources
Further study details as provided by Asociación para Evitar la Ceguera en México:
Primary Outcome Measures:
- Central macular thickening [ Time Frame: 2 weeks after each laser session and 1 and 2 months after last laser session ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Best corrected visual acuity [ Time Frame: 2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Active Comparator: 1: 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.
|
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.
Other Name: Nevanac 0.1%
|
|
Placebo Comparator: 2: placebo
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
Other Name: Systane
|
Detailed Description:
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 |
Criteria
Inclusion Criteria:
- Patients with Severe and proliferative Diabetic Retinopathy
- Symmetric severity grade on both eyes
- Best corrected visual acuity better than 20/80
Exclusion Criteria:
- Clinical significant macular edema
- Lens opacity
- Ocular surgery 6 months or less before recruit
- Uveitis history
- Actual use of topical or systemic non-steroidal anti inflammatory agents
- Actual or history of other macular diseases
- Ocular surface diseases
- Vitreomacular traction syndrome
- Other vascular retinal diseases different to diabetic retinopathy
- Actual or history of use of topical prostaglandin analogues
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801905
Contacts
| Contact: Dulce O Rascon-Vargas, Fellow | (52) 55 10841400 ext 1167 | dorv_md@hotmail.com |
Locations
| 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 | |
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
| 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
No publications provided
| Responsible Party: | Dulce Oliva Rascon-Vargas, Asociación Para Evitar la Ceguera en México I.A.P. |
| ClinicalTrials.gov Identifier: | NCT00801905 History of Changes |
| Other Study ID Numbers: | NEPAFENAC IN PRFC, NEPAFENACO |
| Study First Received: | December 3, 2008 |
| Last Updated: | December 3, 2008 |
| Health Authority: | Mexico: Ethics Committee |
Keywords provided by Asociación para Evitar la Ceguera en México:
|
Macular thickening Macular edema Pan-retinal photocoagulation Nepafenac Topical non-steroidal anti inflammatory agents |
Additional relevant MeSH terms:
|
Edema Macular Edema Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal |
Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013