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

Asociación para Evitar la Ceguera en México

Status and phase: Terminated; Phase 2

Conditions: Macular Edema; Macular Thickening

Treatments: Other: Lubricant; Drug: Nepafenac

Study type: Interventional

Funder types: Other

Identifiers

NCT00801905

NEPAFENACO

NEPAFENAC IN PRFC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups, including a placebo group

1: Nepafenac

Active Comparator group

Description:

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.

Treatment:

Drug: Nepafenac

2: placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Lubricant