Clinical trial NCT00801905: Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation
Official title: Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Macular Thickening
Macular Edema
Keywords: Macular thickening
Macular edema
Pan-retinal photocoagulation
Nepafenac
Topical non-steroidal anti inflammatory agents
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Central macular thickening
timeFrame: 2 weeks after each laser session and 1 and 2 months after last laser session
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociación Para Evitar la Ceguera en México I.A.P.
city: Mexico City
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico I.A.P.
Study officials:
affiliation: Asociación Para Evitar la Ceguera en México I.A.P.
name: Dulce O Rascon-Vargas, Fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación Para Evitar la Ceguera en México I.A.P.
name: Guadalupe Cervantes-Coste
role: STUDY_CHAIR
affiliation: Asociación Para Evitar la Ceguera en México I.A.P.
name: Jans Fromow-Guerra
role: STUDY_DIRECTOR
References: