Volume 14, Number 8
Monday, February 24, 2014


In this issue: (click heading to view article)
######### How Treatment with Anti-VEGF Impacts Quality of Life of Neovascular AMD Patients
######### Efficacy and Safety of Two or More Dexamethasone Intravitreal Implant Injections for the Treatment of Macular Edema Related to RVO
######### Treatment of Progressive Keratoconus with CXL
######### Long-Term Effects of Multiple Intravitreal Anti-VEGF Injections on IOP
######### Briefly

How Treatment with Anti-VEGF Impacts Quality of Life of Neovascular AMD Patients

A team of researchers in Australia assessed the impact of anti-vascular endothelial growth factor (VEGF) treatment in routine medical practice on vision-related quality of life (VRQoL) in neovascular age-related macular degeneration (AMD).

They included 169 patients with neovascular AMD undergoing anti-VEGF treatment in the prospective case series. The researchers performed VRQoL interviews at baseline (n=169), six months (n=138) and 12 months (n=120), routine anti-VEGF treatment with up to monthly follow-ups, and re-treatment as indicated. The Impact of Vision Impairment (IVI) questionnaire was subjected to Rasch analysis to assess its measurement performance and generate interval-level estimates of VRQoL at all time points, anchoring the instrument to its baseline measurement characteristics. The study researchers assessed factors associated with a change in reported VRQoL using generalized linear regression models. The main outcome measure was VRQoL as measured by the IVI using its three subscales: accessing information, mobility and emotional well-being.

The mean age was 70 years (±6 years standard deviation [SD]); 56% were female. Visual acuity (VA) improved by a mean of eight letters (±17 SD), and mean retinal thickness decreased by 87 (±89.7) µm with an average of 6.5 (±2.6) injections over 12 months. Those who lost more than two lines (n=13, 11%) reported worse VRQoL at 12 months on the accessing information and mobility subscales (p=0.007 and p=0.050, respectively). Conversely, those who gained more than two lines (n=29, 24%) reported better VRQoL on the accessing information and emotional well-being subscales (p=0.009 and p=0.008, respectively). Patients who did not experience a change in VA reported no change in their VRQoL. In multivariate analyses, only a change in VA, but not whether the better or worse eye was treated, predicted a change in VRQoL on the accessing information (p=0.004) and the emotional well-being (p=0.008) subscales.

The researchers confirmed that anti-VEGF treatment for neovascular AMD improves patients' VRQoL in those who gain vision and maintains VRQoL in those who maintain VA in their treated eye, irrespective of whether the worse or better eye is treated. Against this background, the best possible outcomes should be aimed for even if the worse eye is treated because a loss of VA in the worse eye will adversely affect patients' VRQoL.

SOURCE: Finger RP, Guymer RH, Gillies MC, Keeffe JE. The impact of anti-vascular endothelial growth factor treatment on quality of life in neovascular age-related macular degeneration. Ophthalmology. 2014; Feb 10. [Epub ahead of print].

Efficacy and Safety of Two or More Dexamethasone Intravitreal Implant Injections for the Treatment of Macular Edema Related to RVO

The following multicenter (26-site), retrospective chart review study evaluated the efficacy, safety and reinjection interval of dexamethasone intravitreal implant (DEX implant) in branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) patients receiving more than two DEX implant treatments.

Data were collected from baseline (at first DEX implant) through three months to si months after last DEX implant.

Patients (n=289) received two to nine (mean, 3.2) DEX implants as monotherapy (29.1% of patients) or with adjunctive treatments/procedures. Mean duration of macular edema before first DEX implant was 18.4 months and mean reinjection interval was 5.6 months. Mean peak change in best-corrected visual acuity (BCVA) from baseline through four weeks to 20 weeks after final DEX implant was +1.0 line (p<0.001). BCVA and central retinal thickness improved significantly from baseline after each of the first six DEX implant injections (p≤0.037); 59.7% of BRVO and 66.7% of CRVO patients achieved two lines or more BCVA improvement. Furthermore, an increase in intraocular pressure (IOP, ≥10 mmHg) occurred in 32.6% of patients; 29.1% used IOP-lowering medication to treat increases associated with DEX implant. Only 1.7% of patients required incisional glaucoma surgery.

In conclusion, retinal vein occlusion patients treated with multiple DEX implant injections, either alone or combined with other therapies, had improved central retinal thickness and visual acuity with each subsequent injection. No new safety concerns developed with multiple implants.

SOURCE: Capone A, Singer MA, Dodwell DG, et al. Efficacy and safety of two or more dexamethasone intravitreal implant injections for treatment of macular edema related to retinal vein occlusion (Shasta Study). Retina. 2014;34(2);342–251.

Treatment of Progressive Keratoconus with CXL

The authors of this prospective clinical study sought to assess the long-term effects of treating 17 patients with progressive keratoconus with ultraviolet A-riboflavin collagen cross-linking (CXL). Three-year results following CXL show stable visual acuity, corneal thickness and corneal biomechanical parameters.

They examined patients preoperatively, at week one, months one, three, six, nine, 12, 24 and 36 after treatment. They also used Reichert's Ocular Response Analyzer to assess uncorrected visual acuity (UCVA) and best spectacle-corrected visual acuity (BSCVA), refraction, biomicroscopy and fundus appearance, intraocular pressure, endothelial cell density (ECD), corneal topography, minimal corneal thickness (MCT), macular optical coherence tomography, axial length and corneal biomechanics.

Comparing the 36-month time point results with pretreatment values, the authors found that UCVA and BSCVA were unchanged. They also noted that steepest meridian keratometry (D) and mean cylinder (D) did not show significant change compared with pretreatment values, but showed a slight increase as compared with the 24-month time point (53.9 vs. 51.7 vs. 52.5, and 10.5 vs. 8.1 vs. 9.2 before, at 24 months, and at 36 months, respectively). The study authors reported that axial length (mm) showed an elongation trend throughout the follow-up period (24.56 vs. 24.61 [p=0.04] vs. 24.71 [p=0.05], before, at 24 months, and at 36 months, respectively). They observed no significant change in ECD, corneal hysteresis and corneal resistance factor, MCT or foveal thickness.

The decreasing trend in keratometry values that the authors observed during the first two years following CXL was no longer evident. Longer follow-up is needed to decide whether it is a first sign of loss of achieved stability and resumption of keratoconus progression.

SOURCE: Goldich Y, Barkana Y, Lior OW, et al. Corneal collagen cross-linking for the treatment of progressive keratoconus: 3-year prospective outcome. Can J Ophtahlmol. 2014;49(1):54–59.

Long-Term Effects of Multiple Intravitreal Anti-VEGF Injections on IOP

Investigators conducted this retrospective cohort study to evaluate the long-term effects of multiple intravitreal anti-vascular endothelial growth factor (VEGF) injections on intraocular pressure (IOP) in eyes with neovascular age-related macular degeneration (AMD) or retinal vein occlusion (RVO).

The study enrolled patients who underwent multiple (more than three) intravitreal anti-VEGF injections and who were followed for more than 12 months after their last injection. The investigators defined IOP elevation as an increase of 5 mmHg over the baseline measurement on two consecutive visits. The frequency of IOP elevation was determined, and a hazard ratio of each putative risk factor for IOP elevation was calculated using the Cox proportional hazard model for the total participants, incorporating underlying disease as a covariate, as well as for each cohort.

A total of 629 eyes with neovascular AMD and 95 eyes with RVO were included in the analysis. According to the study investigators, 20 eyes with neovascular AMD (3.0%) and seven eyes with RVO (7.4%) experienced IOP elevation after multiple anti-VEGF injections, with an overall incidence of 3.7%. In the Cox proportional hazard analysis of total participants, they determined that a diagnosis of RVO (3.424, p=0.005), a history of glaucoma (8.441, p=0.001) and low baseline IOP (0.865, p=0.040) were all significant risk factors for IOP elevation following multiple anti-VEGF injections.

To conclude, a history of multiple intravitreal anti-VEGF injections was not a significant risk factor for IOP elevation in this study. IOP elevation was more common in eyes with RVO than with AMD after anti-VEGF injection.

SOURCE: Kim YJ, Sung KR, Lee KS, et al. Long-term effects of multiple intravitreal anti-vascular endothelial growth factor injections on intraocular pressure. Am J Ophthalmol. 2014; Feb 20. [Epub ahead of print].

  • PIVOTAL PHASE III CLINICAL STUDY FOR DRY EYE INITIATED BY ELEVEN BIOTHERAPEUTICS. Eleven Biotherapeutics announced that patient randomization and dosing are under way in the company's first pivotal Phase III clinical study of EBI-005 for the treatment of moderate to severe dry-eye disease. EBI-005 was designed, engineered and generated using Eleven Biotherapeutics' AMP-Rx platform and is a topically administered interleukin-1 receptor blocker in development for the treatment of dry eye and allergic conjunctivitis. The OASIS study (A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Control In Subjects With Moderate to Severe Dry Eye Disease) will include approximately 650 subjects in the United States, who will be randomized to receive EBI-005 or a vehicle-control. The co-primary endpoints are change in corneal fluorescein staining score and improvement in pain and discomfort. The safety and tolerability of EBI-005 compared to vehicle-control will also be evaluated.
  • TEARLAB TO ACQUIRE OCUHUB TECHNOLOGY. TearLab Corp. has signed a non-binding term sheet to purchase the assets of the OcuHub business unit from AOAExcel Inc., the for-profit subsidiary of the American Optometric Association. While terms of the transaction have not been disclosed, the acquisition is expected to close in March. OcuHub, powered by AT&T and Covisint, is an established, compliant technology platform designed to securely connect eye doctors, patients, healthcare organizations and payers. For more details, click here.
  • SPECIALEYES ADDS CALCULATORS AND TOOLS FOR CUSTOM SOFT CLS TO WEBSITE. SpecialEyes LLC recently unveiled a website upgrade featuring expanded user-specific content and added functionality, including an array of free tools and calculators for eye-care professionals. Practitioners can navigate to the Learning Center to access a prescribing nomogram, custom contact lens fitting guides and other useful tools and information. Two easy-to-use online calculators were also added as part of the upgrade: the Arc Length Calculator and the Over-Refraction Calculator.
  • OCUSOFT LAUNCHES RETAINE PM NIGHTTIME OINTMENT. OCuSOFT Inc. has introduced Retaine PM Nighttime Ointment to keep eyes lubricated and comfortable during sleep and to relieve severe dry eye symptoms. Retaine PM is a preservative-free, oil-based formula packaged in a 5-gram tube. Introductory discount pricing is available to practitioners dispensing from their offices. Visit www.ocusoft.com for more information.

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