ARVO Roundup

ARVO highlights: presentations examine timely retina issues

Five studies seek to break new ground.

By Jerry Helzner, Contributing Editor

Of the thousands of studies presented every year at the Association for Research in Vision and Ophthalmology (ARVO) meeting, hundreds deal with retina-related issues. The recent ARVO conference in Denver was no exception. International researchers produced many timely and interesting retina studies, some of which broke new ground in an effort to settle old dilemmas.

The following works focus on broader issues of interest to retina specialists and general ophthalmologists.

Variations in patients’ response to anti-VEGF

Three retina specialists from Northwestern University pooled the responses of 331 eyes to multiple injections of anti-VEGF therapy over a four-year period from July 2010 to July 2014. Their aim was to identify subgroups of wet AMD patients and their response to anti-VEGF treatment.

Of the 24 eyes that presented with count fingers or worse, only one eye showed improved vision to a Snellen of 20/200 or better over the study period. In addition, 16 eyes that began the study with a Snellen VA deteriorated to count fingers over the course of the study.

During the study period, 170 eyes maintained vision within two lines of baseline, 56 eyes lost more than two lines, and 66 eyes gained more than two lines. Of the eyes that gained more than two lines, 16 received fewer than five injections and 17 eyes received more than 20 injections.

Of the eyes that lost more than two lines, 21 received more than 20 injections.

The researchers concluded there is a wide range of individual responses to anti-VEGF therapy, which poses “a significant challenge” to physicians planning treatment. They said more studies are needed to determine which factors are associated with favorable or poor response to the various anti-VEGF agents.

The study title: Patterns of response to anti-VEGF treatment in a large urban cohort of patients with neovascular age-related macular degeneration.

Blood splatter a problem during intravitreal injections

Researchers from Loyola University (Illinois) and the University of Michigan conducted a study to determine whether blood splattered during intravitreal injections.

One vitreoretinal specialist, wearing a new plastic eye shield with each injection, administered 100 consecutive intravitreal injections. Patients’ eyes received anesthetic via pledgets soaked in 4% lidocaine and were cleaned with Betadine swabs. The 100 shields were subsequently dried and stored. Each shield was sprayed with luminol, a bioluminescence blood detection system. The vitreoretinal specialist also filled out a questionnaire following each injection, recording if there was any blood splatter.

The specialist reported no indication of blood splatter for any injection. But, of the 100 shields, seven were found to have blood splatter.

The study researchers cautioned that blood splatter during intravitreal injections carried the risks of transconjunctival transmission of HIV and viral hepatitis. This study is the first of its kind to document a 7% risk of blood splatter during intravitreal injections.

The poster’s title: “Blood splatter during intravitreal injections.”

Inflammation incidence after anti-VEGF injections

Following up on reports of inflammation after anti-VEGF injections for wet AMD, researchers at the Robert Wood Johnson Medical School (New Brunswick, NJ) conducted a 106-eye study to determine an incidence rate.

Study subjects had received a mean of 18 injections of either ranibizumab (Lucentis, Genentech) or aflibercept (Eylea, Regeneron). Their mean age was 83 years. Some treatment-naïve subjects were also included in the study.

No significant clinical inflammatory reactions were identified in any of the 106 eyes for up to three days following intravitreal injection. The researchers said they intend to bring additional subjects into this study.

The poster’s title: Assessing intraocular inflammation after ranibizumab and aflibercept injections for neovascular AMD.

Decline in reading speeds useful in trials

An interesting sidelight to the MAHALO clinical trial for the treatment of geographic atrophy with lampalizumab (Roche/Genentech) was that the trial included both a reading speed test and a functional reading-independence questionnaire. Researchers from numerous institutions and companies including Johns Hopkins, University of Southern California, Los Angeles, and Genentech initiated the test on the premise that a decline in reading ability might occur in advance of a loss in measurable BCVA and serve as a valuable tool for assessing patients.

One hundred English-speaking subjects participated in the test, with an average baseline reading speed at 105 words per minute. At 18 months, the average speed had dropped to 82 words per minute; the greatest decline occurred between 12 and 18 months. Those patients whose reading speed dropped below 80 words per minute reported the greatest problems with reading independently.

The researchers concluded that tests of reading speed and functional reading independence could be a useful addition to future clinical trials related to geographic atrophy.

The poster’s title: Reading speed in geographic atrophy: change over time and relation to patient-reported functioning.

Fame Extension study shows improvement with Iluvien

Researcher Baruch Kuppermann, MD, PhD, invited patients with DME who had participated in the phase 3 FAME trial for the Iluvien implant (fluocinolone acetonide intravitreal implant, Alimera Sciences,) to take part in the FAME Extension study. Fluocinolone acetonide is a long-term, sustained-release implant. The study was conducted to test a new microinjector.

Sixty-four subjects from the FAME study agreed to participate. Each received a single 0.2 μg/d FAc (fluocinolone acetonide) implant in the same eye treated during the initial study.

Patients were on average 68 years old (mean DME duration = 7.32 years). Mean time that elapsed between exiting the initial study and receiving treatment in the new study was 585 days. The mean BCVA for these 64 patients entering the extension was 62.7 ETDRS letters. After 12 months, BCVA showed a modest gain of approximately two letters and an improved retinal anatomy from a baseline of 316.6 μm to 261.0 μm. In general, 0.2 μg/d FAc was well tolerated. Adverse events were consistent with the class: mean IOP increased by approximately 2.5 mm Hg; four patients developed ocular hypertension, and cataract and IOP-lowering surgeries were performed on one patient each.

Dr. Kuppermann concluded that, on average, BCVA was maintained and retinal anatomy improved in this new study. The safety profile was consistent with the class; data from individual patients will provide details on the spectrum of response. The results support the use of 0.2 μg/d FAc implants for the treatment of DME, he wrote.

The poster’s title: Long-term treatment with Iluvien fluocinolone acetonide (FAc) implants in patients with diabetic macular edema. OM