Pam Harrison

September 13, 2013

TORONTO, Ontario — The use of a topical ocular nonsteroidal anti-inflammatory drug (NSAID) before and after cataract surgery leads to meaningful reductions in postoperative macular edema in patients with pre-existing retinopathy, new research shows.

"Macular edema is a common cause of poor visual outcome after uneventful cataract surgery," Rishi Singh, MD, from the Cole Eye Institute at the Cleveland Clinic Foundation, told Medscape Medical News. "And we found that treatment with nepafenac ophthalmic suspension 0.1% improved outcomes, compared with placebo, in preventing macular edema and maintaining visual acuity in patients with diabetic retinopathy after cataract surgery."

Dr. Singh presented the findings here at the 31st Annual Meeting of the American Society of Retina Specialists. First results from this study were published in Clinical Ophthalmology (2012;6:1259-1269).

The multicenter, randomized, double-masked, placebo-controlled, parallel-group study involved 260 patients with mild, moderate, or severe proliferative disease.

The 130 patients in the nepafenac group received 1 drop of 0.1% three times prior to surgery, on the day of surgery, and then daily for 90 days after surgery. Patients in both groups also received standard-of-care prednisolone acetate 4 times a day for at least 2 weeks after surgery.

As a primary outcome measure, the investigators assessed the percentage of patients who developed macular edema in the 90 days after cataract surgery. Macular edema was defined as an increase of at least 30% in macular thickness from the preoperative baseline level.

Table. Development of Macular Edema After Cataract Surgery

Macular edema Nepafenac 0.1% (n = 125) Placebo (n = 126) P value
Within 30 days 2.4% 8.7% .029
Within 60 days 2.4% 15.1% <.001
Within 90 days 3.2% 16.7% <.001

 

As a secondary outcome measure, the investigators assessed the percentage of patients with a decrease of more than 5 letters in best-corrected visual acuity from day 7 after cataract surgery to day 90.

At 90 days, fewer patients in the nepafenac group than in the placebo group experienced this decrease in visual acuity (2.5% vs 11.5%; P < .006).

"Probably the most surprising result of the study was the percentage of patients with a greater than 3-line visual acuity gain," Dr. Singh noted. This was better in the nepafenac group than in the placebo group (56.8% vs 41.9%; P = .019).

In addition, mean central subfield macular thickness and mean percent change from baseline in macular volume were both significantly lower in the nepafenac group than in the placebo group from day 14 to day 90 (P ≤ .005 for every comparison).

More concerning, Dr. Singh noted, is the fact that neither central subfield macular thickness nor macular volume had returned to baseline in the placebo group at 90 days.

No treatment-related adverse events were seen in either group.

In the United States, nepafenac 0.1% is indicated for the treatment of pain and inflammation associated with cataract surgery, but this is the first study of its use to prevent macular edema in patients with diabetes.

Session cochair George Williams, MD, from the Oakland University William Beaumont School of Medicine in Rochester, Michigan, asked Dr. Singh if the effects of nepafenac 0.1% are specific to this particular topical NSAID, and noted his financial relationship with Alcon Laboratories, the manufacturer of the drug.

"No," said Dr. Singh, explaining that nepafenac 0.1% is "just one in a class of the newer-generation NSAIDs."

"Nevertheless, I think these newer-generation NSAIDs have a lot more penetration than the older NSAIDs," Dr. Singh noted. Not necessarily retinal penetration, he explained, maybe just body penetration. "Even so, it appears that the drug does work very well for this indication."

Dr. Singh reports receiving a research grant from and serving as a consultant for Alcon Laboratories.

31st Annual Meeting of the American Society of Retina Specialists. Presented August 27, 2013.

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