From the editors of Review of Ophthalmology:
Monday, September 9, 2019
SEPTEMBER IS HEALTHY AGING MONTH
In this issue: (click heading to view article)
SD-OCT Predictors of Visual Outcomes after Ranibizumab for ME due to RVO
Researchers evaluated spectral-domain optical coherence tomography features associated with baseline vision and visual outcomes after seven monthly ranibizumab doses in the prospective, multicenter Study Evaluating Dosing Regimens for Treatment with Intravitreal Ranibizumab Injections in Subjects with macular Edema following Retinal Vein Occlusion (SHORE).
As part of the post-hoc analysis of prospective clinical trial data, researchers studied 202 participants in the 15-month, Phase IV study comparing monthly versus pro re nata ranibizumab after seven monthly doses in eyes with retinal vein occlusions with macular edema.
Researchers assessed the baseline SD-OCT images for: 1) central subfield thickness; 2) presence of vitreomacular adhesion, vitreomacular traction or epiretinal membrane; 3) presence, location and amount of intraretinal or subretinal fluid (IRF or SRF); 4) presence, location and amount of hyperreflective foci (HF); 5) disorganization of retinal inner layers (DRIL); and 6) disruption of external limiting membrane (ELM); ellipsoid zone (EZ); and interdigitation zone (IZ). Researchers performed univariate and multivariable regression analyses to evaluate the association of these features with baseline BCVA and change in BCVA after seven initial monthly ranibizumab injections.
The main outcome measure included the association of SD-OCT features with baseline BCVA and change in BCVA after seven monthly ranibizumab injections. Here were some of the findings:
• Prior to therapy, worse baseline BCVA was associated with ERM presence (p=
0.0045), thicker SRF (p=
0.0006), larger size of intraretinal cysts (p=
0.0015) as well as higher percentage of DRIL (p<
0.0001), percentage of ELM disruption (p<
0.0001), percentage EZ disruption (p=
0.0003) and percentage of IZ disruption (p=
• In multivariate models, only the percentage of ELM disruption independently impacted baseline BCVA (p<
0.0001). After seven monthly ranibizumab injections, mean BCVA improved by 18.3 ±12.6 ETDRS letters in treated eyes.
• The only factors independently associated with BCVA gain after seven monthly ranibizumab treatments were younger age (p<
0.0001) and worse baseline BCVA (p<
Researchers determined that, while SD-OCT features might be associated with presenting vision in eyes with macular edema due to RVO, most eyes treated with ranibizumab experience substantial vision gains, and only older age and better baseline BCVA limited visual improvements.
SOURCE: Yiu G, Welch J, Wang Y, et al. SD-OCT Predictors of visual outcomes after ranibizumab treatment for macular edema due to retinal vein occlusion. Ophthalmology Retina 2019; Aug. 28. [Epub ahead of print].
Choroidal Thickness in Keratoconus
Investigators wrote that determination of choroidal thickness in keratoconus patients may aid in better understanding and managing the disease. They added that choroidal thickness might be a potential marker for disease activity in keratoconus patients. In this study, investigators aimed to determine choroidal thickness in keratoconus patients and compare the results with the age-matched control group.
The prospective study had a control group. Investigators measured and recorded keratometry and thinnest corneal thickness in keratoconus patients. They measured choroidal thickness of all subjects using an optical coherence tomography device (Spectralis OCT, version 6.0, Heidelberg Engineering) with an enhanced depth imaging mode without pupil dilation. They compared mean choroidal thickness of keratoconus patients with healthy subjects.
A total of 160 eyes of 80 healthy subjects, and 160 eyes of 80 keratoconus patients were included in the study. Here were some of the findings:
• Mean thinnest corneal thickness of the keratoconus patients was 449.7 ±3.2 µm.
• Mean corneal keratometry values in the keratoconus patients were 53.2 ±0.2 D, and cylindrical refraction error was 3.3 ±0.1 D.
• Mean choroidal thickness was 363.9 ±59.8 µm in keratoconus patients and 328.4 ±67.2 µm in the healthy subjects.
• A very significant difference was found between keratoconus patients and healthy subjects in terms of choroidal thickness.
• There was no statistically significant correlation between choroidal thickness and thinnest corneal thickness in keratoconus patients (p=0.814).
Investigators determined that choroidal thickness was found to be increased in keratoconus patients. They added that choroidal thickness could potentially become a new clinical marker for disease activity in keratoconus patients
SOURCE: Bilgin B, Karadag AS. Choroidal thickness in keratoconus. Int Ophthalmol 2019; Aug 20. [Epub ahead of print].
Long-Term Regular Exercise and IOP: The Hisayama Study
Scientists evaluated the efficacy and safety profile of intravitreal ranibizumab 0.5 mg in Asian patients with visual impairment due to macular edema secondary to branch retinal vein occlusion, as part of a 12-month, Phase III, double-masked study.
Scientists evaluated the association between long-term regular exercise (exercise frequency and exercise time) and five-year changes in intraocular pressure in a Japanese population.
This population-based, cohort study was conducted in 2007. A total of 3,119 Japanese patients ages ≥ 40 years underwent eye examinations including intraocular pressure measurement with a noncontact tonometer. Of these, 1,871 subjects (801 men and 1,070 women) who underwent IOP measurement in 2012 participated. Scientists assessed the associations of exercise frequency and exercise time with intraocular pressure using a linear regression model, adjusted for age and possible risk factors that can affect intraocular pressure.
The mean five-year intraocular pressure change ± standard deviation was -0.84 ±1.9 mmHg. After adjustment for age, sex, systolic blood pressure, diabetes, total cholesterol, high-density lipoprotein cholesterol, body mass index, waist circumference, smoking habit, alcohol intake, work intensity levels and IOP at baseline, scientists observed that increased exercise frequency (times/week) and increased exercise time (min./week) were both significantly associated with reduced IOP (p<
0.05 each). In the subgroup analyses based on the presence/absence of possible confounding risk factors, there was no evidence of heterogeneity among all subgroups (p for heterogeneity >0.2).
Scientists found that increased exercise frequency levels and increased exercise time were both independently associated with reduced IOP levels after adjustment for confounding factors.
SOURCE: Fujiwara K, Yasuda M, Hata J, et al. Long-term regular exercise and intraocular pressure: The Hisayama Study. Graefes Arch Clin Exp Ophthalmol 2019; Aug 21. [Epub ahead of print].
Panretinal Photocoagulation for DR in RIDE & RISE Trials: Not “One and Done”
Researchers evaluated panretinal photocoagulation treatment and retreatment patterns in patients with diabetic retinopathy and diabetic macular edema, as part of a post hoc analysis of the Phase III RIDE and RISE clinical trials of ranibizumab for the treatment of DME.
A total of 759 patients who were randomized for treatment took part in the study in which researchers assessed PRP treatment patterns and clinical experiences by baseline PRP treatment status. Main outcome measures included number and timing of on-study PRP treatment sessions received through month 24. Researchers also assessed time to any new proliferative events (composite endpoint). Here were some of the findings:
• At baseline, ∼25 percent of patients in RIDE and RISE had received PRP treatment before enrollment (22.2 percent, 24.4 percent, and 25.4 percent of patients in the sham, ranibizumab 0.3 mg, and ranibizumab 0.5 mg arms, respectively).
• In patients without prior PRP at baseline (n=577), 9.5 percent of sham-treated individuals received ≥1 PRP treatment through month 24 compared with 1.1 percent and 1.6 percent of patients treated with ranibizumab 0.3 mg and ranibizumab 0.5 mg, respectively (p<
0.001 for both ranibizumab arms vs. sham).
• In patients with prior PRP at baseline (n=182), 19.3 percent of sham-treated patients received ≥1 PRP treatment through month 24.
• No ranibizumab-treated patients with prior PRP at baseline required additional on-study PRP through month 24 (p<
0.001 for both ranibizumab arms vs. sham).
• Ranibizumab treatment also significantly reduced clinical DR progression among individuals who received prior PRP.
• By month 24 in individuals with prior PRP at baseline, the probability of experiencing a new proliferative event was 10.3 percent and 9.9 percent in patients treated with ranibizumab 0.3 mg and ranibizumab 0.5 mg, respectively, compared with 39.4 percent in sham-treated patients (p<
• Overall, sham-treated patients, including those patients who were PRP-naïve at baseline who went on to require PRP, experienced more clinical events than ranibizumab-treated patients.
Researchers wrote that, in RIDE and RISE, PRP treatment was not a “one-and-done” procedure, with on-study PRP retreatment occurring in individuals both with and without prior PRP treatment at baseline. Ranibizumab treatment reduced on-study PRP treatment and DR progression regardless of prior PRP treatment status at baseline.
Source: Gonzalez VH, Wang P-W, Quezada Ruiz C, et al. Panretinal photocoagulation for diabetic retinopathy in the RIDE and RISE trials: Not “One and Done.” Ophthalmology 2019; Aug 21. [Epub ahead of print].
Essilor Instruments Launches Next-Generation Retinal Imaging System
Essilor Instruments USA announced the launch of the RETINA800 non-mydriatic fundus camera. The company says that the speedy, fully automatic retinal image capture of RETINA800 is designed to provide high-quality images, and enable the easy screening and detection of retinal pathologies. The camera will be on display at the Essilor Instruments booth #LP6065 at Vision Expo West (Sept. 18 to 21) in Las Vegas for those interested in a hands-on demonstration. Learn more.
REGENXBIO Announces Agreement with Clearside
Regenxbio announced an option and license agreement for exclusive worldwide rights to Clearside's proprietary, in-office SCS Microinjector for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration, diabetic retinopathy and other conditions for which anti-vascular endothelial growth factor treatment is currently the standard of care. Regenxbio plans to evaluate RGX-314 using Clearside's SCS Microinjector for in-office, non-surgical delivery into the suprachoroidal space, while continuing to advance its RGX-314 subretinal delivery program currently in development for wet AMD and DR. Read more.
Oxurion Completes Enrolment of Phase I Clinical Trial Evaluating THR-687
Oxurion NV announced the completion of enrollment of patients in a Phase I trial with THR-687. The open-label, multicenter, dose escalation study is evaluating the safety of a single intravitreal injection of escalating dose levels (three) of THR-687 for the treatment of patients with diabetic macula edema. A total of 12 patients with DME have been enrolled in the U.S.-based study. THR-687 is a novel pan-RGD integrin antagonist currently being developed as a potential treatment for patients with diabetic eye disease. Read more.
Advancing Eyecare Announces Acquisition of Ophthalmic Instruments
Advancing Eyecare, a U.S. distributor of ophthalmic instruments, announced the acquisition of fellow instrument distributor Ophthalmic Instruments. Advancing Eyecare was formed in 2019 by Atlantic Street Capital in partnership with Lombart Instrument and Marco Ophthalmic. Read more.
Allegro to Present Phase II Risuteganib Intermediate Dry AMD Study at EURETINA Congress & The Retina Society Annual Meeting
Allegro Ophthalmics announced that results of its U.S. Phase II study evaluating risuteganib (Luminate) for the treatment of intermediate nonexudative age-related macular degeneration will be presented during the 19th European Society of Retina Specialists (EURETINA) Congress being held Sept. 5-8 in Paris, and at The Retina Society 2019 Annual Meeting, which is being held Sept. 11-15 in London. In June, Allegro announced topline results of the risuteganib Phase II intermediate dry AMD clinical trial, which met its primary endpoint with 48 percent of patients in the risuteganib arm at week 28 gaining ≥8 letters in visual acuity from baseline, compared with 7 percent of patients in the sham group at week 12 (p=0.013). Risuteganib was found to be safe with no reported drug-related serious adverse events. Read more.
RESEARCH ON RIGHTEYE'S EYE TRACKING DATA
RightEye announced the results from a recent study published in the peer-reviewed journal Concussion that shows how RightEye’s FDA-cleared technology accurately measured deficits in certain eye movements that result from a concussion. The company says that the data provided by RightEye eye tracking technology offered an objective, reliable and quantifiable way of differentiating between individuals with different severities of concussion, as well as providing guidance on the path to recovery. Read more.
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