Efficacy of Nepafenac Ophthalmic Suspension 0.1% in Improving Clinical Outcomes Following Cataract Surgery in Patients with Diabetes: an Analysis of Two Randomized Studies

Overview

Journal Clin Ophthalmol

Publisher Dove Medical Press

Specialty Ophthalmology

Date 2017 Jun 13

PMID 28603408

Citations 5

Authors

Rishi P Singh

Giovanni Staurenghi

Ayala Pollack

Adeniyi Adewale

Thomas M Walker

Dana Sager

Robert Lehmann

Affiliations

Soon will be listed here.

Abstract

Objective: To assess the efficacy of nepafenac 0.1% ophthalmic suspension in improving the clinical outcomes following cataract surgery (CS) in patients with nonproliferative diabetic retinopathy.

Methods: In two similar multicenter, randomized studies, patients received either nepafenac 0.1% or vehicle, instilled three times daily starting a day prior to surgery and continuing for 90 days postoperatively. A post hoc analysis of these two studies was conducted to assess 1) the likelihood for development of postoperative macular edema (ME), based on the percentage of patients who developed ME (≥30% increase from preoperative baseline in central subfield macular thickness) within 90 days following CS and 2) best-corrected visual acuity (BCVA) endpoints, including the percentage of patients with a BCVA improvement of ≥15 letters from preoperative baseline to Day 14 and maintained through Day 90. Results for individual studies and their pooled estimates (only visual acuity endpoints) are reported. Primary inference was based on odds ratio (OR).

Results: This post hoc analysis included 411 patients (nepafenac 0.1%: 205; vehicle: 206). The incidence of postoperative ME within 90 days of CS was notably lower in the nepafenac-treated patients than in vehicle-treated patients (study 1: 3.2% vs 16.7%; OR =0.2, 95% confidence interval [CI] =0.1, 0.5, =0.001; study 2: 5.0% vs 17.5%; OR =0.2, 95% CI =0.1, 0.8, =0.018). A higher percentage of nepafenac-treated patients than vehicle-treated patients gained ≥15 letters from preoperative baseline to Day 14, which was maintained through Day 90 (study 1: 38.4% vs 21.4%; OR =2.4, 95% CI =1.4, 4.2, =0.003; study 2: 35.0% vs 25.0%; OR =1.6, 95% CI =0.8, 3.2, =0.172; pooled: 37.1% vs 22.8%; OR =2.0, 95% CI =1.3, 3.1, =0.001). The odds of >5-letter and >10-letter loss in BCVA from postoperative Day 7 were higher in vehicle-treated than in nepafenac-treated patients.

Conclusion: These results support the clinical benefit of prophylactic use of nepafenac 0.1% for reducing the risk of postoperative ME and for improvement in BCVA outcomes following CS in patients with nonproliferative diabetic retinopathy.

Citing Articles

Inflammation: The Link between Neural and Vascular Impairment in the Diabetic Retina and Therapeutic Implications.

Ramos H, Hernandez C, Simo R, Simo-Servat O Int J Mol Sci. 2023; 24(10).

PMID: 37240138 PMC: 10218195. DOI: 10.3390/ijms24108796.

Pseudophakic Cystoid Macular Oedema (PCME) Prevention in Patients with Non-Proliferative Diabetic Retinopathy (NPDR)-Randomized Controlled Trial.

Jukic A, Kasalica Zuzul R, Pavan J, Lovric M, Kozmar A, Plavec D Medicina (Kaunas). 2022; 58(11).

PMID: 36422204 PMC: 9694649. DOI: 10.3390/medicina58111667.

Functional and anatomical evaluation of the effect of nepafenac in prevention of macular edema after phacoemulsification in diabetic patients.

Mokbel T, Saleh S, Abdelkader M, El-Khouly S, Abou Samra W, Mamdouh M Int J Ophthalmol. 2019; 12(3):387-392.

PMID: 30918805 PMC: 6423393. DOI: 10.18240/ijo.2019.03.06.

The Effects of Uncomplicated Cataract Surgery on Retinal Layer Thickness.

Kurt A, Kilic R J Ophthalmol. 2018; 2018:7218639.

PMID: 29967695 PMC: 6008803. DOI: 10.1155/2018/7218639.

Effects of calcium dobesilate on Nrf2, Keap1 and HO-1 in the lenses of D-galactose-induced cataracts in rats.

Sun J, Wang B, Hao Y, Yang X Exp Ther Med. 2018; 15(1):719-722.

PMID: 29399076 PMC: 5772489. DOI: 10.3892/etm.2017.5435.

References

Wielders L, Lambermont V, Schouten J, Biggelaar F, Worthy G, Simons R . Prevention of Cystoid Macular Edema After Cataract Surgery in Nondiabetic and Diabetic Patients: A Systematic Review and Meta-Analysis. Am J Ophthalmol. 2015; 160(5):968-981.e33. DOI: 10.1016/j.ajo.2015.07.032. View

Krepler K, Biowski R, Schrey S, Jandrasits K, Wedrich A . Cataract surgery in patients with diabetic retinopathy: visual outcome, progression of diabetic retinopathy, and incidence of diabetic macular oedema. Graefes Arch Clin Exp Ophthalmol. 2002; 240(9):735-8. DOI: 10.1007/s00417-002-0530-7. View

Wolf E, Braunstein A, Shih C, Braunstein R . Incidence of visually significant pseudophakic macular edema after uneventful phacoemulsification in patients treated with nepafenac. J Cataract Refract Surg. 2007; 33(9):1546-9. DOI: 10.1016/j.jcrs.2007.05.018. View

Walters T, Raizman M, Ernest P, Gayton J, Lehmann R . In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac. J Cataract Refract Surg. 2007; 33(9):1539-45. DOI: 10.1016/j.jcrs.2007.05.015. View

FERGUSON V, Spalton D . Continued breakdown of the blood aqueous barrier following cataract surgery. Br J Ophthalmol. 1992; 76(8):453-6. PMC: 504315. DOI: 10.1136/bjo.76.8.453. View

Henricsson M, Heijl A, Janzon L . Diabetic retinopathy before and after cataract surgery. Br J Ophthalmol. 1996; 80(9):789-93. PMC: 505613. DOI: 10.1136/bjo.80.9.789. View

Rossetti L, Chaudhuri J, Dickersin K . Medical prophylaxis and treatment of cystoid macular edema after cataract surgery. The results of a meta-analysis. Ophthalmology. 1998; 105(3):397-405. DOI: 10.1016/S0161-6420(98)93018-4. View

Almeida D, Khan Z, Xing L, Bakar S, Rahim K, Urton T . Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification. J Cataract Refract Surg. 2012; 38(9):1537-43. DOI: 10.1016/j.jcrs.2012.04.034. View

Wang Q, Yao K, Xu W, Chen P, Shentu X, Xie X . Bromfenac sodium 0.1%, fluorometholone 0.1% and dexamethasone 0.1% for control of ocular inflammation and prevention of cystoid macular edema after phacoemulsification. Ophthalmologica. 2013; 229(4):187-94. DOI: 10.1159/000346847. View

10.

Hariprasad S, Callanan D, Gainey S, He Y, Warren K . Cystoid and diabetic macular edema treated with nepafenac 0.1%. J Ocul Pharmacol Ther. 2007; 23(6):585-90. DOI: 10.1089/jop.2007.0062. View

11.

Dowler J, Sehmi K, Hykin P, Hamilton A . The natural history of macular edema after cataract surgery in diabetes. Ophthalmology. 1999; 106(4):663-8. DOI: 10.1016/S0161-6420(99)90148-3. View

12.

Donnenfeld E, Holland E, Solomon K, Fiore J, Gobbo A, Prince J . A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. Am J Ophthalmol. 2011; 152(4):609-617.e1. DOI: 10.1016/j.ajo.2011.03.018. View

13.

Zaczek A, Olivestedt G, Zetterstrom C . Visual outcome after phacoemulsification and IOL implantation in diabetic patients. Br J Ophthalmol. 1999; 83(9):1036-41. PMC: 1723171. DOI: 10.1136/bjo.83.9.1036. View

14.

Pollack A, Staurenghi G, Sager D, Mukesh B, Reiser H, Singh R . Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy. Br J Ophthalmol. 2016; 101(4):423-427. DOI: 10.1136/bjophthalmol-2016-308617. View

15.

Kessel L, Tendal B, Jorgensen K, Erngaard D, Flesner P, Andresen J . Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review. Ophthalmology. 2014; 121(10):1915-24. DOI: 10.1016/j.ophtha.2014.04.035. View

16.

Tzelikis P, Vieira M, Hida W, Motta A, Nakano C, Nakano E . Comparison of ketorolac 0.4% and nepafenac 0.1% for the prevention of cystoid macular oedema after phacoemulsification: prospective placebo-controlled randomised study. Br J Ophthalmol. 2014; 99(5):654-8. DOI: 10.1136/bjophthalmol-2014-305803. View

17.

Ke T, Graff G, Spellman J, Yanni J . Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: II. In vitro bioactivation and permeation of external ocular barriers. Inflammation. 2000; 24(4):371-84. DOI: 10.1023/a:1007001131987. View

18.

Chu C, Johnston R, Buscombe C, Sallam A, Mohamed Q, Yang Y . Risk Factors and Incidence of Macular Edema after Cataract Surgery: A Database Study of 81984 Eyes. Ophthalmology. 2015; 123(2):316-323. DOI: 10.1016/j.ophtha.2015.10.001. View

19.

Eriksson U, Alm A, Bjarnhall G, Granstam E, Wikberg Matsson A . Macular edema and visual outcome following cataract surgery in patients with diabetic retinopathy and controls. Graefes Arch Clin Exp Ophthalmol. 2010; 249(3):349-59. DOI: 10.1007/s00417-010-1484-9. View

20.

Donnenfeld E, Perry H, Wittpenn J, Solomon R, Nattis A, Chou T . Preoperative ketorolac tromethamine 0.4% in phacoemulsification outcomes: pharmacokinetic-response curve. J Cataract Refract Surg. 2006; 32(9):1474-82. DOI: 10.1016/j.jcrs.2006.04.009. View