Aflibercept for Myopic CNV
In the first phase 3 study to evaluate intravitreal aflibercept in patients with myopic choroidal neovascularization (CNV), Ikuno et al. found that the drug was safe and effective.
A total of 122 patients with high myopia were enrolled in this double-masked, sham-controlled study (known by the acronym MYRROR) and randomized 3:1 to receive intravitreal injection of 2 mg of aflibercept or sham. In the aflibercept arm, patients (n = 91) received one injection at baseline and additional aflibercept as often as every four weeks based on disease activity through week 44. If active treatment was not needed, patients were given a sham injection to maintain the masking. In the sham arm, patients (n = 31) received injections every four weeks through week 20. At week 24, patients in this arm were given aflibercept—then, depending on disease activity, they received either aflibercept or sham injections every four weeks through the end of the study. Over the course of the trial, the patients in both groups received a median of three aflibercept injections.
The primary outcome measure was mean change in best-corrected visual acuity at week 24. At this point, patients in the aflibercept group had gained a mean of 12.1 letters, while those in the sham group had lost two letters. By week 48, patients in the aflibercept group had gained 13.5 letters, while those in the sham/aflibercept group had gained three letters.
Seven patients, all of whom were in the aflibercept group, experienced serious treatment-emergent adverse events. Four of the events were systemic and three were ophthalmic, with one patient experiencing a macular hole in the treated eye.
Refractive and Nonrefractive Visual Loss: Impact on Disability
Does one type of visual loss have a greater impact on a person’s functional ability than another? Zebardast et al. investigated this question and found that it does.
The researchers assessed participants in the first round of the Salisbury Eye Evaluation (SEE) study, a population-based study of older Americans that evaluated a broad range of vision-related abilities. For this cross-sectional study, the effects of uncorrected refractive error (URE) were compared with those of nonrefractive visual impairment (VI) on performance and disability measures.
Main outcome measures included the following: 1) objective measures of ability, notably timed performance of mobility (walking and climbing stairs) and near-vision tasks (such as inserting a key into a lock), 2) self-reported issues with driving, and 3) self-reported visual difficulties measured by the activities of daily vision scale.
Of the 2,469 individuals in the SEE study, 191 had decreased visual acuity as a result of VI, and 132 had decreased acuity from URE. Those with VI demonstrated poorer objective and subjective visual functioning in all metrics examined, while those with URE had difficulty with most but not all of the categories examined. Overall, the relative impact of VI on disability was considerably greater than that of URE, the researchers said.
The study had some limitations, the researchers acknowledged. For instance, they were unable to consistently identify the causes of nonrefractive vision loss and thus could not differentiate between specific eye diseases.
MMC in Excimer Laser Ablation Techniques
In an Ophthalmic Technology Assessment, Majmudar et al. reviewed the published literature on the efficacy and safety of mitomycin-C (MMC) when used as an adjunctive treatment in corneal excimer laser ablation procedures. They found good evidence of effectiveness for the intraoperative use of MMC but noted that several issues remain to be settled, including optimal dosage. They also presented several clinical pearls and highlighted opportunities for future research.
For this report, the authors selected 26 published articles that were considered to be of high or medium clinical importance. Of these, 10 studies were rated as level I evidence, five were rated as level II evidence, and the remaining 11 were rated as level III evidence.
The majority of articles reviewed support the role of MMC as an adjunctive treatment in surface ablation techniques, the authors said. When MMC is applied in the appropriate concentration and confined to the central cornea, it inhibits haze formation and improves visual acuity outcomes, particularly in highly myopic eyes.
While some studies found a reduction in endothelial cell density following MMC use—though no adverse outcomes were noted with as much as five years of follow-up—the clinical significance of this finding remains uncertain, the authors said. Other areas in need of additional research include optimal dosage and MMC’s effectiveness when used in lower myopic and hyperopic ablations.
Vitreous Seeds in Retinoblastoma: Classification and Response to Melphalan
Francis et al. examined whether classification of vitreous seeds in retinoblastoma is useful as a clinical tool, particularly with regard to disease response to intravitreal melphalan. They found that regression and response vary by seed classification. Moreover, seed classification can be predictive not only of time to regression but also of the number of doses, median dose, and cumulative dose of intravitreal melphalan required.
For this retrospective cohort study, the researchers evaluated 87 eyes of 87 patients. The median follow-up was 20.3 months (range, 2-56 months), and the median age at treatment was 43.6 months (range, 11-216 months). Eleven eyes had class 1 seeds (defined as “dust”), 60 had class 2 seeds (“spheres”), and 16 had class 3 seeds (“cloud”).
Median time to regression was 0.6 months for class 1, 1.7 months for class 2, and 7.7 months for class 3. The median number of injections ranged from three for class 1 to five for class 2 and eight for class 3. Median doses of melphalan were 20, 30, and 32.5 μg for the three classes, respectively; and the corresponding median cumulative dose of melphalan was 60 μg, 161 μg, and 229 μg.
Ophthalmology summaries are written by Jean Shaw and edited by Susan M. MacDonald, MD.
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