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
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