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

NCT ID: NCT00801905

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-03-31

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.

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.

Conditions

Macular Thickening; Macular Edema

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nepafenac

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

Lubricant

Intervention Type: 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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: OTHER

Other Intervention Names

Nevanac 0.1%; Systane

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dulce O Rascon-Vargas, Fellow

Role: PRINCIPAL_INVESTIGATOR

Asociación Para Evitar la Ceguera en México I.A.P.

Guadalupe Cervantes-Coste

Role: STUDY_CHAIR

Asociación Para Evitar la Ceguera en México I.A.P.

Jans Fromow-Guerra

Role: STUDY_DIRECTOR

Asociación Para Evitar la Ceguera en México I.A.P.

Locations

Asociación Para Evitar la Ceguera en México I.A.P.

Mexico City, , Mexico

Asociacion para Evitar la Ceguera en Mexico I.A.P.

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

NEPAFENACO

Identifier Type: -

Identifier Source: secondary_id

NEPAFENAC IN PRFC

Identifier Type: -

Identifier Source: org_study_id