From the editors of Review of Ophthalmology:
In this issue: (click heading to view article)
Predictive Activation Biomarkers of Treatment-naive Asymptomatic CNF in AMD
Researchers assessed the long-term evolution of treatment-naive quiescent choroidal neovascularization in age-related macular degeneration to identify predictive activation biomarkers.
Subjects included those with quiescent CNV who had undergone comprehensive ophthalmological exams, including fluorescein and indocyanine green angiographies, structural optical coherence tomography and OCT angiography. Researchers performed qualitative and quantitative analyses of structural OCT and OCTA images during the study period. At the last follow-up evaluation, they divided the enrolled eyes into two groups: eyes with quiescent CNV converting to exudative AMD and those not progressing to eAMD.
Sixty-eight eyes of 68 individuals were enrolled in the study. Mean follow-up duration was 40 ±28 months using multimodal imaging and 22 ±13 months using OCTA. Here were some of the findings:
• On structural OCT, quiescent CNV not converting to eAMD showed a preferential growth of the pigment epithelium detachment greatest linear diameter (p=
0.009), whereas the eAMD group presented a preferential growth of the pigment epithelium detachment maximal height (p<
0.0001) during the study period.
• Quantitative analysis of choriocapillaris OCT angiograms confirmed the CNV area growth during follow-up (from 4.18 ±4.77 mm2
at baseline to 5.10 ±5.06 mm2
at the last follow-up visit; p=
Researchers recommended close follow-up of quiescent CNV patients to early identify predictive activation biomarkers of treatment-naive quiescent CNV.
SOURCE: Serra R, Coscas F, Boulet JF, et al. Predictive activation biomarkers of treatment-naive asymptomatic choroidal neovascularization in age-related macular degeneration. Retina 2019; Jun 21. [Epub ahead of print].
Use of Topical IOP Lowering Medications in the United States
Investigators aimed to determine changes in topical intraocular pressure lowering medication use in the United States from 1999 to 2014, using a series of eight nationally representative, weighted cross-sectional surveys of U.S. residents performed every two years in that timeframe.
On two-year cycles, professional interviewers performed in-home interviews of a representative sample of the nation as part of the NHANES study. They asked participants, “In the past month, have you used or taken medication for which a prescription is needed?” Adults over age 40 who responded to this question were included in the analysis. The primary outcome was number of U.S. adults using topical IOP lowering medication. Secondary outcomes included the number and types of medications used. Here were some of the findings:
• There was no change in the number of adults using topical IOP lowering medications over the time period studied (p=
0.74), with 1.4 percent (CI, 0.9 to 1.8 percent) of U.S. residents on IOP lowering medications between 1999 and 2000, and 1.4 percent of U.S. residents (CI, 1.1 to 1.8 percent) on topical medications between 2013 and 2014.
• There was no change in the number of medications per patient over the period of the study (p=
• There was a significant increase in the use of prostaglandin-analogs and combination medications, and a decrease in the use of beta-blockers (all p<
In contrast to the increase in glaucoma medication use seen in several other developed nations, use in the United States remained stable between 1999 and 2014. Investigators suggested this might have been due to differential use of other procedures. They added that future studies of IOP lowering medications incorporating the effect of new agents and minimally invasive surgeries would be warranted to confirm this notion.
SOURCE: Lowry EA, Chansangpatch S, Lin S C. Use of topical intraocular pressure lowering medications in the United States population. J Glaucoma 2019; June 24. [Epub ahead of print].
Efficacy of Standard vs. Accelerated Epi-off Corneal Cross-linking Protocols
Scientists compared the one-year efficacy of accelerated and standard 5.4 J/cm2
protocols of cross-linking in the treatment of progressive keratoconus, as part of a systematic review.
Two members of the research team searched Scopus, Pubmed, ISI, Ovid, Science Direct and Cochrane databases independently for publications between January 2010 and December 2016. The outcomes of interest were uncorrected distance visual acuity, corrected visual acuity, manifest refraction spherical equivalent, maximum keratometry in the central 3 mm, minimum keratometry in the central 3 mm, and corneal thickness in the apex or thinnest point at baseline and one year after CXL.
Of the 453 papers found in the preliminary search, 23 were included in the final analysis. Analysis of one-year changes showed that longer irradiation times were associated with a greater corneal flattening effect, although there was no difference in terms of vision or refraction improvement.
Scientists concluded that efficacy was comparable among different CXL protocols, so they recommended using the standard method in cases where maximum flattening was expected, such as for young people and severe cases.
SOURCE: Miraftab M, Hashemi H, Abdollahi M, et al. The efficacy of standard versus accelerated epi-off corneal cross-linking protocols: A systematic review and sub-group analysis. Int Ophthalmol 2019; June 20. [Epub ahead of print].
OCTA Metrics Predict Progression of DR & Development of DME
Researchers prospectively evaluated the relationship of optical coherence tomography angiography metrics with diabetic retinopathy progression and development of diabetic macular edema, as part of a prospective, observational study. Participants included 205 eyes from 129 individuals with diabetes mellitus followed up for at least two years.
All subjects underwent OCTA with a swept-source OCT (DRI-OCT Triton, Topcon). Researchers obtained individual OCTA images of superficial capillary plexus (SCP) and deep capillary plexus (DCP) from IMAGEnet6. After quality checks, they obtained automated measurements of foveal avascular zone area, FAZ circularity, and vessel density (VD) and fractal dimension (FD) of SCP and DCP. Researchers performed Cox proportional hazard models to examine the relationship between baseline OCTA metrics and DR progression and DME development. Here were some of the findings:
• Over a median follow-up of 27.14 months (interquartile range, 24.16 to 30.41 months), 28 eyes out of the 205 eyes (13.66 percent) developed DR progression.
• Of 194 eyes without DME at baseline, 17 eyes (8.76 percent) developed DME.
• Larger FAZ area (HR, .829 per SD increase; CI, 1.332 to 2.512), lower VD (HR, 1.908 per SD decrease; CI, 1.303 to 2.793) and lower FD (HR, 4.464 per SD decrease; CI, 1.337 to 14.903) of DCP were significantly associated with DR progression, after adjusting for established risk factors (DR severity, glycated hemoglobin, diabetes duration, age and mean arterial blood pressure at baseline).
• Lower VD of SCP (HR, 1.789 per SD decrease; CI, 1.027 to 4.512) was associated with DME development.
• Compared with the model with established risk factors alone, the addition of OCTA metrics improved the predictive discrimination of DR progression (FAZ area of DCP, C-statistics 0.723 vs. 0.677, p<
0.001; VD of DCP, C-statistics 0.727 vs. 0.677, p=
0.001; FD of DCP, C-statistics 0.738 vs. 0.677, p<
0.001) and DME development (VD of SCP, C-statistics 0.904 vs. 0.875, p=
Researchers wrote that FAZ area, in addition to VD and FD of DCP predicted DR progression, while VD of SCP predicted DME development. They added that their findings provided evidence to support the idea that OCTA metrics improved the risk assessment of DR progression and DME development beyond traditional risk factors.
Source: Sun Z, Tang FY, Wong R, et al. Optical coherence tomography angiography metrics predict progression of diabetic retinopathy and development of diabetic macular edema: a prospective study. Opthalmology. 2019; Jun 25. [Epub ahead of print].
AbbVie to Acquire Allergan
AbbVie and Allergan announced that the companies have entered into a definitive transaction agreement under which AbbVie will acquire Allergan in a cash and stock transaction for a transaction equity value of approximately $63 billion, based on the closing price of AbbVie's common stock of $78.45 on June 24, 2019. AbbVie describes the deal as a "transformational transaction for both companies" that "achieves unique and complementary strategic objectives." Read more.
FDA to Review DORC NDA Drug to Stain ILM During Vitreoretinal Surgery
The Dutch Ophthalmic Research Center received FDA notification that its New Drug Application for Brilliant Blue G Ophthalmic Solution was accepted for review. The proposed indication is to selectively stain the internal limiting membrane. Brilliant Blue G Ophthalmic Solution is intended for injection onto the inner retinal surface, enabling the ILM to be clearly stained and distinguished from unstained retina, facilitating removal. If approved, Brilliant Blue G Ophthalmic Solution would be the first FDA approved product for this orphan indication. Read more.
Dompé Enrolls First Patient in Phase IIb Trial Investigating Novel Mechanism of Action in Moderate to Severe Dry-eye Disease
Dompé announced the first patient was enrolled in Study NGF0118, a multicenter, randomized, double-masked, vehicle-controlled, parallel group study to evaluate the safety and efficacy of rhNGF eye solution vs. the vehicle in individuals with moderate to severe dry-eye disease. The study will analyze approximately 300 patients at 11 U.S. sites for four weeks of active treatment followed by 12 weeks of observation. In a separate clinical study, the company says it plans to collect biomarker information from DED patients to develop “tailored” treatments. Read more.
Katairo Announces First Patient Treated in STARTT Study
Katairo GmbH announced the treatment of the first patient in the company’s placebo-controlled study of Remofuscin in adults with Stargardt’s disease. The trial will enroll approximately 90 patients in up to four European countries. Read more.
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