NEPAF: Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation

Sponsor

Asociación para Evitar la Ceguera en México (Other)

Overall Status

Unknown status

CT.gov ID

NCT00801905

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Macular Thickening Macular Edema	Drug: Nepafenac Other: Lubricant	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Effect of Topical Nepafenac in Macular Thickening Related to Pan-Retinal Photocoagulation

Study Start Date :

Aug 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Systane

Arm

Intervention/Treatment

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

Other Names:

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

Other Names:

Systane

Outcome Measures

Primary Outcome Measures

Central macular thickening [2 weeks after each laser session and 1 and 2 months after last laser session]

Secondary Outcome Measures

Best corrected visual acuity [2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Asociación Para Evitar la Ceguera en México I.A.P.	Mexico City		Mexico	004030
2	Asociacion para Evitar la Ceguera en Mexico I.A.P.	Mexico City		Mexico	04030

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.