Article Date: 7/1/2007

Longer-term Lucentis Study
SUBSPECIALTY NEWS

Longer-term Lucentis Study

Repeated Treatments Are Safe and Can Sustain Vision Gains.

JERRY HELZNER, SENIOR EDITOR

■ A landmark study that followed 67 wet AMD patients for as long as 3.8 years indicates that individuals treated regularly with Lucentis can sustain vision gains for at least several years without experiencing major side effects.

Andrew Antoszyk, MD, of Charlotte Eye, Ear, Nose and Throat Associates, Charlotte, NC, a principal investigator, said the study followed patients who had participated in one of 3 earlier phase 1/2 trials of Lucentis. It is the longest independent study demonstrating the safety and efficacy of Lucentis over an extended time period.

"Patients from the phase 1/2 trials were allowed to enroll in this extension study to evaluate the long-term safety of Lucentis," says Dr. Antoszyk. "We found that, on average, patients who received regular injections of 0.5 mg of Lucentis were able to maintain their initial vision gains with stable lesion characteristics. We found no new safety signals that could be associated with longer-term use of Lucentis."

Correction: In "Management of submacular hemorrhage associated with AMD" by Belinda L. Shirkey, MD, published in the March 2007 issue of Retinal Physician, an incorrect dosage for the administration of tPA was provided on page 23 of the article. The correct dosage should be 125 μg/mL. Both the author and the editors of Retinal Physician regret this error and apologize for any confusion.

The study, which was presented as a poster at the recent ARVO meeting, found that the most common ocular side effects were conjunctival hemorrhage, reported in 30% of the patients, retinal hemorrhage, reported in 27% of the patients, and reduced visual acuity, in 21% of the patients in the study.

"Conjunctival hemorrhage was almost always the result of the injection itself," says Dr. Antoszyk. "Retinal hemorrhage was reported as a side effect but we hypothesize that it is primarily associated with disease progression."

Nonocular side effects included hypertension in 25% of the patients, arterial thromboembolic events in 10% of patients, and epistaxis in 3% of patients. These side effects were not surprising in a patient population averaging 78 years of age.

"Our conclusion was that repeated intravitreal injections of Lucentis were well tolerated and that the side effects reported in this study were relatively minor," says Dr. Antoszyk.

Dr. Antoszyk noted that patients treated monthly with Lucentis showed a slightly better ability to retain their vision gains than those treated at longer dosing intervals at the discretion of the investigator.

"There was a slight decrease in visual acuity from the study's baseline in some of the patients whose retreatments were done on what could be termed an 'as needed' basis," Dr. Antoszyk notes. "But determining the timing of retreatment was not a primary goal of the study. The primary goal was to determine the longer-term safety and tolerability of Lucentis."

In another Lucentis-related study presented as a poster at ARVO, investigators led by Thomas A. Ciulla of the Midwest Eye Institute in Indianapolis reviewed 1-year data from the pivotal phase 3 MARINA and ANCHOR trials to determine whether untreated fellow eyes of patients with bilateral wet AMD were affected in any way by the injections. Patients in MARINA and ANCHOR received treatment in only 1 eye, even if bilateral disease was present.

The study found that "the absence of any apparent VA benefit in the fellow eyes of the ranibizumab groups, together with the absence of key serious ocular events, supports the expectation that any systemic circulation from the study eye to the fellow eye, if it occurs, is of limited clinical relevance."

The findings of both the Antoszyk and Ciulla studies tend to allay concerns that ocular injections of the anti-VEGF therapy Lucentis could cause unwanted local or systemic side effects.



Retinal Physician, Issue: July 2007