Real-world Impact of IOP Control on Rates of RNFL Loss

Scientists looked at the impact of intraocular pressure control on rates of change of spectral-domain optical coherence tomography retinal nerve fiber layer thickness in a real-world large clinical population, as part of a retrospective cohort study.

A total of 85,835 IOP measurements and 60,223 SD-OCT tests from 14,790 eyes of 7,844 patients were included. Data were extracted from the Duke Glaucoma Registry. Scientists included all records from individuals with a minimum of six months of follow-up, and at least two good-quality SD-OCT scans and two clinical visits using with Goldmann applanation tonometry. Eyes were categorized according to the frequency of visits, with IOP below cutoffs of 21 mmHg, 18 mmHg and 15 mmHg over time. Rates of change for global RNFL thickness were obtained using linear mixed models and classified as:

• slow, if change was slower than -1 μm/year;
• moderate, if between -1 and -2 μm/year; and
• fast, if faster than -2 μm/year.

Multivariable models were adjusted for age, gender, race, diagnosis, central corneal thickness, follow-up time and baseline disease severity. Main outcome measures included rates of change of SD-OCT RNFL thickness according to levels of IOP control. Here were some of the findings:

• Eyes had a mean follow-up of 3.5 ±1.9 years.
• The average rate of change in RNFL thickness was -0.68 ±0.59 μm/year.
• Each 1 mmHg higher mean IOP was associated with 0.05 μm/year faster RNFL loss (p<0.001) after adjustment for potentially confounding variables.
• In faster-progressing eyes, at all follow-up visits, 41 percent had IOP <21 mmHg, 20 percent had IOP <18mmHg and 9 percent had IOP <15mmHg.

Scientists reported that IOP was significantly associated with rates of progressive RNFL loss in a real-world large clinical population. In addition, they wrote that eyes with stricter IOP control over follow-up visits had less chance of exhibiting fast deterioration. Scientists pointed out that their findings may assist clinicians in establishing target pressures in clinical practice.

SOURCE: Jammal AA, Thompson AC, Mariottoni EB, MD, et al. Real-world impact of intraocular pressure control on rates of retinal nerve fiber layer loss in a large clinical population. Ophthalmology 2020; June 20. [Epub ahead of print].

MA Incidence & Progression in nAMD Eyes Treated with VEGF Inhibitors Using a T&E or PRN Regimen: MANEX Study

Researchers compared the incidence and progression of macular atrophy in eyes with neovascular age-related macular degeneration treated with anti-vascular endothelial growth factor agents using a treat-and-extend or pro re nata regimen over four years in a real-life setting, as part of a multicenter, retrospective, comparative study.

Participants included 264 individuals with treatment-naïve nAMD. Consecutive patients with nAMD received anti-VEGF therapy according to a T&E (n=163) or PRN (n=101) regimen. Eyes were included if they had received anti-VEGF injections for at least four years, and had annual fundus autofluorescence (FAF) and optical coherence tomography imaging using the Heidelberg Spectralis. Two masked graders independently delineated areas of MA from serial FAF images using Heidelberg region finder software, and growth rates were calculated. Incident MA was assessed using proportional hazard ratios.

Main outcome measures included MA incidence and progression over four years, association between treatment strategy and number of injections. Here were some of the findings:

• At baseline, MA was present in 24 percent of T&E group and 20 percent of the PRN group (p=0.32).
• At year four, in the T&E group, 27 percent of eyes (34/124) without baseline MA had detectable MA; and in the PRN group, 25 percent of eyes (20/81) without baseline MA had detectable MA.
• In eyes with MA at baseline, the mean square root area of MA progressed by a rate of 0.4 ±0.2 in the T&E group and by 0.4 ±0.1 mm/year in the PRN group (p=0.23).
• Multivariate analysis for baseline predictors of MA growth including older age, poorer baseline VA and presence of RAP revealed a higher risk of greater MA progression (p=0.03).
• Regression analysis demonstrated no association between T&E and PRN treatment strategies relative to the risk of developing new MA during four years of follow-up, or risk of progression of pre-existing MA at year four (p=0.692).

Researchers reported that, over four years, neither incidence nor progression of macular atrophy in nAMD eyes treated with anti-VEGF injections were influenced by the treatment regimen or injection frequency. They added that eyes treated with a T&E regimen received more injections and had better visual outcomes compared with those treated with a PRN approach.

Source: Spooner KL, Fraser-Bell S, Cozzi M, et al. Macular atrophy incidence and progression in eyes with neovascular age-related macular degeneration treated with VEGF inhibitors using a treat-and-extend or a pro-re-nata regimen. Four year results of the MANEX study. Ophthalmology Retina 2020; June 13. [Epub ahead of print].

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U.S. Government Sues Regeneron

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