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

Macular Edema Clinical Trial

— NEPAF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00801905
• Other study ID #: NEPAFENAC IN PRFC
• Secondary ID: NEPAFENACO
• Status: Terminated
• Phase: Phase 2
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Edema
• Macular Thickening

Intervention

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:
• 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

Locations

Country	Name	City	State
Mexico	Asociacion para Evitar la Ceguera en Mexico I.A.P.	Mexico City
Mexico	Asociación Para Evitar la Ceguera en México I.A.P.	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickening		2 weeks after each laser session and 1 and 2 months after last laser session
Secondary	Best corrected visual acuity		2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed