Inflammation is associated with diabetic retinopathy development and progression, and previous studies have demonstrated that omega-3 polyunsaturated fatty acids (PUFAs) have anti-inflammatory properties. Therefore, investigators say that the goal of their study was to determine if omega-3 PUFAs, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) were associated with decreased risk and severity of retinopathy in individuals with type 2 diabetes.
In a combined population of 1,356 individuals with type 2 diabetes from the Multi-Ethnic Study of Atherosclerosis (MESA) and Genetics of Latino Diabetic Retinopathy (GOLDR) cohorts, odds ratios using logistic regression were determined to assess the association between PUFAs and retinopathy.
Here are some of the findings:
- In 1,356 participants with type 2 diabetes, individuals in the fourth quartile of DHA were 17 percent less likely to have retinopathy compared to the first quartile (p=0.009; CI, 0.72 to 0.95).
- Secondary analysis revealed a 38 percent lower severity of retinopathy in individuals in the fourth compared to the first quartile of DHA (p=0.006; CI, 0.44 to 0.87) and EPA+DHA (p=0.004; CI, 0.44 to 0.85).
- No significant associations were observed between EPA and retinopathy.
Investigators found DHA was inversely associated with presence and severity of diabetic retinopathy. They suggested that increased intake of dietary sources of DHA may provide some protection against retinopathy in individuals with type 2 diabetes and warrants more research as a preventative option.
Retina 2023; Jan 30 [Epub ahead of print].
Weir NL, Guan W, Karger AB, et al.
Blood Pressure Associated With GCC Thinning
Researchers investigated the association of baseline blood pressure measures with rates of change of the macular ganglion cell complex in patients with central or moderate to advanced glaucoma damage at baseline.
This prospective cohort study, conducted from August 2021 to August 2022, used data from patients in the Advanced Glaucoma Progression Study at the University of California, Los Angeles. Participants were between 39 and 80 years of age and had more than four macular imaging tests, and two or more years of follow-up. They had a diagnosis of glaucoma with either central damage or a visual field mean deviation worse than -6 dB.
The main outcome was the association of blood pressure measures with ganglion cell complex rates of change. Macular ganglion cell complex thickness rates of change were estimated with a Bayesian hierarchical model. This model included relevant demographic and clinical factors. Blood pressure measures, intraocular pressure and interactions were added to the model to assess the association of baseline blood pressure measures with global ganglion cell complex rates of change.
The cohort included 105 eyes from 105 participants. The mean age was 66.9 ±8.5 years; 10-2 visual field mean deviation was -8.3 ±5.3 dB; follow-up time was 3.6 ±0.4 years; and 67 patients (63.8 percent) were female. The racial and ethnic makeup of the cohort was 55 white (52.4 percent), 23 Asian (21.9 percent),15 African American (14.3 percent) and 12 Hispanic (11.4 percent). Here are some of the findings:
- In multivariable analyses, female sex, history of taking blood-pressure medications, higher IOP, thicker central corneal thickness, shorter axial length, higher contrast sensitivity at 12 cycles per degree and higher baseline 10-2 visual field mean deviation were associated with faster ganglion cell complex thinning.
- Lower diastolic blood pressure was associated with faster rates of ganglion cell complex thinning at higher intraocular pressures.
- For IOPs of 8 and of 16 mmHg (10 and 90 percent quantiles, respectively), every 10 mmHg-lower increment of diastolic blood pressure was associated with 0.011 µm/y slower and -0.130 µm/y faster rates of ganglion cell complex thinning, respectively.
Researchers found a combination of lower diastolic blood pressure and higher intraocular pressure at baseline was associated with faster rates of ganglion cell complex thinning. The researchers say that these findings support consideration of evaluating and addressing diastolic blood pressure as a therapeutic measure in patients with glaucoma if supported by appropriate clinical trials.
JAMA Ophthalmol 2023; Feb 9 [Epub ahead of print].
Mohammadzadeh V, Su E, Mohammadi M, et al.
DME Treatment Cost Analysis
Investigators wrote that the DRCR Retina Network Protocol AC showed no significant difference in visual acuity outcomes over two years between treatment with aflibercept monotherapy and initial bevacizumab followed by a switch to aflibercept for suboptimal response in treating diabetic macular edema. As such, they wrote that understanding the estimated cost and cost-effectiveness of these approaches is important.
The investigators evaluated the cost and cost-effectiveness of aflibercept monotherapy vs. bevacizumab-first strategies for DME treatment, as part of an economic evaluation/preplanned secondary analysis of a randomized clinical trial. Participants were ages 18 years or older, with center-involved DME and best-corrected visual acuity of 20/50 to 20/320, enrolled between December 15, 2017, and November 25, 2019.
Between February and July 2022, the incremental cost-effectiveness ratio (ICER) in cost per quality-adjusted life-year (QALY) over two years was assessed. Efficacy and resource utilization data from the randomized clinical trial were used with health utility mapping from the literature and Medicare unit costs.
The study included 228 participants. The median age was 62 (range: 34 to 91 years), 116 (51 percent) were female, 117 (51 percent) were white, 60 (26 percent) were Hispanic and 44 (19 percent) black, and with one study eye. The aflibercept monotherapy group included 116 participants, and the bevacizumab-first group included 112, of whom 62.5 percent were eventually switched to aflibercept. Here are some of the findings:
- Over two years, the cost of aflibercept monotherapy was $26,504 (CI, $24,796 to $28,212) vs. $13,929 (CI, $11,984 to $15,874) for the bevacizumab-first group, a difference of $12,575 (CI, $9,987 to $15,163).
- The aflibercept monotherapy group gained 0.015 (CI, -0.011 to 0.041) QALYs using the better-seeing eye and had an ICER of $837,077 per QALY gained compared with the bevacizumab-first group.
- Aflibercept could be cost-effective with an ICER of $100,000 per QALY if the price per dose were $305 or less, or the price of bevacizumab was $1,307 or more per dose.
Investigators wrote that, as always, variability in individual needs will influence clinician and patient decisions about how to treat specific eyes with DME. However, they found that the bevacizumab-first group costs averaged approximately $12,600 less over two years compared with aflibercept monotherapy, potentially conferring substantial cost savings without sacrificing visual acuity gains.
JAMA Ophthalmol 2023; Feb 2 [Epub ahead of print].
Hutton DW, Glassman AR, Liu D, et al.
OPT-302 Phase IIb Results
Researchers wrote that neovascular age-related macular degeneration is driven by vascular endothelial growth factors-A, -C and -D. They added that intravitreal injections of anti-VEGF-A drugs are the standard of care but don’t inhibit VEGF-C and -D, which may explain why many patients fail to respond fully. This trial aimed to test the safety and efficacy of OPT-302 (Opthea, Princeton, N.J.), a biologic inhibitor of VEGF-C and -D, in combination with the anti-VEGF-A inhibitor ranibizumab.
The dose-ranging, Phase IIb, randomized, double-masked, sham-controlled trial enrolled participants with treatment-naïve nAMD from 109 sites across Europe, Israel and the United States.
Participants were randomized to six four-weekly intravitreal injections of 0.5-mg OPT-302, 2-mg OPT-302 or sham, plus intravitreal 0.5-mg ranibizumab.
The primary outcome was mean change in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity at 24 weeks. Secondary outcomes (comparing baseline to week 24) were the proportion of participants gaining or losing ≥15 ETDRS BCVA letters; area under the ETDRS BCVA over time curve; change in spectral-domain optical coherence tomography central subfield thickness (CST); and change in intraretinal fluid and subretinal fluid on SD-OCT.
Of 366 participants recruited December 2017 to November 2018, 122, 123 and 121 were randomized to 0.5 mg OPT-302, 2.0 mg OPT-302 or sham, respectively. Here are some of the findings:
- Mean (± standard deviation) visual acuity gain in the 2-mg OPT-302 group was significantly superior to sham (+14.2 ±11.61 vs. +10.8 ± 11.52 letters; p=0.01).
- The 0.5-mg OPT-302 group wasn’t significantly different to sham (+9.44 ±11.32 letters; p=0.83).
- Compared to sham, the secondary BCVA outcomes favored the 2-mg OPT-302 group, with structural outcomes favoring both OPT-302 dosage groups.
- Adverse events were similar across groups, with 16 (13.3 percent) participants in the lower dose, 7 (5.6 percent) participants in the higher dose and 10 (8.3 percent) participants in the sham group developing at least one serious adverse event.
- Two unrelated deaths both occurred in the sham arm.
Researchers concluded that significantly superior vision gain was observed with OPT-302 2-mg combination therapy vs. standard of care, with a favorable safety profile.
Ophthalmology 2023; Feb 6 [Epub ahead of print].
Jackson TL, Slakter J, Buyse M, et al.