Macular Thickening, Macular Edema
Conditions
Keywords
Macular thickening, Macular edema, Pan-retinal photocoagulation, Nepafenac, Topical non-steroidal anti inflammatory agents
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.
Interventions
DRUGNepafenac
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.
OTHERLubricant
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
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central macular thickening | 2 weeks after each laser session and 1 and 2 months after last laser session |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity | 2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed |
Countries
Mexico
Outcome results
None listed