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

Information source: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Thickening; Macular Edema

Intervention: Nepafenac (Drug); Lubricant (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Asociación para Evitar la Ceguera en México

Official(s) and/or principal investigator(s):
Dulce O Rascon-Vargas, Fellow, Principal Investigator, Affiliation: Asociación Para Evitar la Ceguera en México I.A.P.
Guadalupe Cervantes-Coste, Study Chair, Affiliation: Asociación Para Evitar la Ceguera en México I.A.P.
Jans Fromow-Guerra, Study Director, Affiliation: Asociación Para Evitar la Ceguera en México I.A.P.

Overall contact:
Dulce O Rascon-Vargas, Fellow, Phone: (52) 55 10841400, Ext: 1167, Email: dorv_md@hotmail.com

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Central macular thickening

Secondary outcome: Best corrected visual acuity

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dulce O Rascon-Vargas, Fellow, Phone: (52) 55 10841400, Ext: 1167, Email: dorv_md@hotmail.com

Asociacion para Evitar la Ceguera en Mexico I.A.P., Mexico City 04030, Mexico; Recruiting
Guadalupe Cervantes-Coste, Phone: (52) 55 10841400, Ext: 1167, Email: gpecervantes@hotmail.com
Jans Fromow-Guerra, Phone: (52) 55 10841400, Ext: 1167, Email: fromow@servidor.unam.mx

Asociación Para Evitar la Ceguera en México I.A.P., Mexico City 004030, Mexico; Recruiting
Dulce O Rascon-Vargas, Fellow, Phone: (52) 55 10841400, Ext: 1167, Email: dorv_md@hotmail.com

Additional Information

Starting date: August 2008
Last updated: December 3, 2008

Page last updated: August 23, 2015

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