Volume 6, Number 2
February 2010

 

WELCOME to Review of Ophthalmology"s Retina Online e-newsletter. Each month, Medical Editor Philip Rosenfeld, MD, PhD, and our editors provide you with this timely and easily accessible report to keep you up to date on important information affecting the care of patients with vitreoretinal disease.



OD-OS, Inc. Appoints Falzon as COO and President
Developer of Navigated Retina Laser Therapy, OD-OS, has announced the appointment of Peter Falzon...

New SLT Lens from Volk Provides Clear Chamber Angle Views
Volk Optical"s new SLT Lens is tailored to the needs of selective laser trabeculoplasty procedures...

And More...

Comparing Treatment Outcomes of Bevacizumab and Ranibizumab for AMD

In this comparative, retrospective case series, researchers compared visual acuity (VA) outcomes after bevacizumab or ranibizumab treatment for age-related macular degeneration (AMD).

They followed 452 patients in this retrospective study of exudative AMD treated with anti-vascular endothelial growth factor drugs; treated 324 patients with bevacizumab and 128 patients with ranibizumab. The researchers followed all treatment-naïve patients who received either bevacizumab or ranibizumab for 1 year and recorded baseline characteristics and VA using standard descriptive statistics. They used VA as the main outcome measure.

At 12 months, the distribution of VA improved in both groups with 22.9% of bevacizumab and 25.0% of ranibizumab attaining ≥20/40. The study researchers observed improvement in vision in 27.3% of the bevacizumab group and 20.2% of the ranibizumab group. The mean number of injections at 12 months was 4.4 for bevacizumab and 6.2 for ranibizumab and according to the researchers, there were 8 (2%) deaths in the bevacizumab group and 4 (3%) in the ranibizumab group. Two patients developed endophthalmitis in the bevacizumab group and the ranibizumab group. They researchers reported that the bevacizumab group had slightly worse acuity at baseline, but that both groups showed improvement and stability of vision over time.

They concluded that both treatments seem to be effective in stabilizing VA loss and they noticed no difference in VA outcome between the two treatment groups. Because the study is a nonrandomized comparison, selection bias could mask a true treatment difference. According to the researchers, results from the Comparison of the Age-Related Macular Degeneration Treatment Trials will provide more definitive information about the comparative effectiveness of these drugs.

Source: Fong DS, Custis P, Howes J, Hsu JW. Intravitreal bevacizumab and ranibizumab for age-related macular degeneration: a multicenter, retrospective study. Ophthalmol 2010;117(2):298-302.

 

 

ALLERGAN AD GOES HERE

 

 

Coapplication of Recombinant Tissue Plasminogen Activator and Bevacizumab for Neovascular AMD

The authors of this German consecutive interventional case series evaluated the efficacy and safety of pars plana vitrectomy (ppV) with subretinal coapplication of recombinant tissue plasminogen activator (rtPA) and bevacizumab, and fluid-gas exchange for neovascular age-related macular degeneration (AMD) with submacular hemorrhage (SMH). Included were 12 patients with neovascular AMD with SMH with a maximum history of 14 days.

All patients underwent ppV with subretinal coapplication of rtPA and bevacizumab, and fluid-gas (20% SF6) exchange and phakic patients underwent concomitant cataract surgery. The authors applied additional injections of bevacizumab intravitreally 4 and 8 weeks postop. They noted that complete displacement of SMH from the fovea was achieved in 9 of 12 patients and that the mean best-corrected visual acuity (BCVA) improved significantly from preop logMAR 1.9 (range 3.0 to 0.3) at 4 weeks postop (p=0.01) and to logMAR 0.9 (range 1.6 to 0.2) at 12 weeks postop (p=0.006). The study authors reported that the mean improvement of BCVA 4 weeks postop as compared with preop was logMAR 0.7 (range -0.2 to 2.3) and that the mean improvement of BCVA 12 weeks postop as compared with preop was logMAR 0.96 (range -0.3 to 2.8). Overall, at 12 weeks postop, BCVA had improved in 10 patients, remained unchanged in one patient and worsened in one patient.

According to the authors, ppV with subretinal coapplication of rtPA and bevacizumab, and fluid-gas exchange effectively displaces SMH and improves visual acuity in most patients.

Source: Treumer F, Klatt C, Roider J, Hillenkamp J. Subretinal coapplication of recombinant tissue plasminogen activator and bevacizumab for neovascular age-related macular degeneration with submacular haemorrhage. Br J Ophthalmol 2010;94(1):48-53.

Disease Progression in Bilateral GA

Analysis was performed in 156 eyes of 78 patients with bilateral geographic atrophy (GA) to determine the degree of concordance for progression rate, size of atrophy and visual acuity (VA) in patients with bilateral GA due to age-related macular degeneration (AMD).

In this German study, best-corrected VA (BCVA) was determined with Early Treatment Diabetic Retinopathy Study (ETDRS) charts and GA was quantified in digital fundus autofluorescence images (excitation, 488 nm; emission, >500 nm) by semiautomated imaging analysis. Additionally, a linear, two-level, random-effects model was used to assess the natural course of disease and the concordance correlation coefficient (CCC) was calculated to assess the degree of agreement between disease characteristics of the left and right eyes. To compare measurements in the eyes, Bland-Altman plot were applied.

It was reported that CCC between the eyes was 0.310 (95% CI, 0.097–0.495) for VA, 0.706 (95% CI, 0.575–0.801) for GA size and 0.756 (95% CI, 0.644–0.837) for GA progression rate. There was considerable discrepancy between both eyes for GA despite the fact that Bland-Altman plots revealed high concordance for the progression rate.

GA progression in bilateral atrophic AMD is a symmetrical process; however, GA size may differ substantially between the eyes. It was determined that high concordance in intraindividual disease progression in the presence of a high degree of interindividual variability indicates an influence by genetic and/or environmental factors, rather than nonspecific aging changes. The relatively small concordance of GA size in this cohort may indicate asymmetric evolution of the disease in affected individuals. These results may be useful in the design of future clinical trials designed to slow the rate of GA progression.

Source: Fleckenstein M, Adrion C, Schmitz-Valckenberg, et al. Concordance of disease progression in bilateral geographic atrophy due to AMD. Invest Ophthalmol Vis Sci 2010;51(2):637-642.


Treatment of CRVO with Bevacizumab

Investigators retrospectively re-evaluated 10 patients with central retinal vein occlusion (CRVO) who were initially part of one of the first published case series on the short-term effects of bevacizumab in patients with CRVO.

They re-evaluated 10 patients with CRVO who were initially part of one of the first published case series on the short-term effects of bevacizumab (patients were invited for a follow-up visit 2 years after their initial bevacizumab injection). According to the investigators, the study endpoints were changes in visual acuity (VA) and central macular edema (CME) compared to 1) baseline values and 2) short-term values after the initial injection.

The investigators noted that short-term visual acuity (VA) gain had been 2.9 lines 3 weeks after the first bevacizumab injection and that two years later, mean VA gain vs. baseline was 1.6 lines. Low baseline VA and good response to the first injection correlated positively with higher long-term VA gains (Pearson correlation of r=0.50 and r=0.66). Moreover, there was no correlation for injection number, occlusion time or CME changes with long-term VA gain.

The study investigators reported that the initial short-term VA gain after bevacizumab treatment was not always maintained over a 2-year period, despite repeated injections. Patients with low baseline VA and good response to the first injection seemed to benefit most from repeated bevacizumab injections.

Source: Stahl A, Struebin I, Hansen LL, et al. Bevacizumab in central retinal vein occlusion: a retrospective analysis after 2 years of treatment. Eur J Ophthalmol 2010;20(1):180-185.


Response of Macular Edema Due to CRVO or BRVO to Intravitreal Bevacizumab Therapy

To evaluate prognostic factors of response to intravitreal bevacizumab therapy of macular edema (ME) due to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO), patients in this German study with ME due to CRVO (32 patients) or BRVO (38 patients) were administered intravitreal bevacizumab (2.5 mg/0.1 ml) at baseline and every 6 to 8 weeks if optical coherence tomography (OCT) showed persistent or recurrent ME.

Visual acuity (EDTRS), ophthalmic examination and OCT were performed at baseline and at all follow-up visit and six to 8 weeks after first injection, baseline factors (visual acuity, central retinal thickness, age and gender) were analyzed retrospectively between patients with resolved ME (group 1) and persisting ME (group 2). Baseline factors of patients with resolved ME since first injection (group A), with recurrent ME since baseline (group B) and with persistent ME since baseline (group C) were compared at last visit.

It was determined that in CRVO patients, central retinal thickness (CRT) and patients' age are prognostic predictors in bevacizumab therapy. Age of CRVO patients differed significantly between groups 1 and 2 after first injection, while CRT only showed a strong trend to thinner CRT. Age and CRT differed statistically significantly between groups A, B and C at last visit. None of the investigated factors revealed any prognostic value in BRVO patients. Moreover, in CRVO and BRVO patients, final CRT is correlated with the CRT after first injection.

CRT and age of patients have prognostic value in bevacizumab therapy of ME due to CRVO, it was concluded. CRVO patients who benefit from therapy are significantly younger and have a lower CRT at baseline than patients with persisting ME. In BRVO patients, no predictive factors for effectiveness of bevacizumab therapy could be observed.

Source: Ach T, Hoeh AE, Schaal KB, et al. Predictive factors for changes in macular edema in intravitreal bevacizumab therapy of retinal vein occlusion. Graefes Arch Clin Exp Ophthalmol 2010;248(2):155-159.


Effect of Pegaptanib Sodium on Macular Edema Secondary to BRVO

Researchers conducted this prospective, randomized, dose-finding study to assess the efficacy and safety of intravitreous pegaptanib sodium (Macugen, EyeTech Pharmaceuticals/Pfizer Inc) for macular edema secondary to branch retinal vein occlusion (BRVO).

Included in this study were 20 subjects from three clinical practices in the United States with BRVO of more than 1 month's and fewer than 6 months' duration; best-corrected visual acuity (BCVA) 70 to 25 Early Treatment Diabetic Retinopathy Study (ETDRS) letters inclusive (approximately 20/40 to 20/320 Snellen); and central foveal thickness of 250µm or more. The researchers randomized subjects 3:1 to intravitreous injections of pegaptanib 0.3 or 1 mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48. Change from baseline to week 54 in BCVA, center point thickness, central subfield thickness and macular volume as measured by optical coherence tomography were the principal efficacy outcomes.

A total of 15 subjects received pegaptanib 0.3 mg and 5 received pegaptanib 1 mg and 18 subjects completed the 54-week follow up. The researchers reported that the results were similar in both the 0.3- and 1-mg groups and that overall improvements from baseline to week 54 occurred in mean BCVA (+14 ± 13 letters), center point thickness (-205 ± 195 µm), central subfield thickness (-201 ± 153 µm) and macular volume (-2.2 ± 1.6 mm³). They noted that the response was rapid after the first injection, with a mean BCVA improvement of 11 ± 7 letters at 1 week from the baseline of 56 ± 12 letters (approximately 20/80 Snellen). They saw one retinal detachment and no cases of endophthalmitis or traumatic cataract.

Intravitreous pegaptanib offers a promising alternative as a treatment for macular edema secondary to BRVO, the researchers concluded.

Source: Wroblewski JJ, Wells JA, Gonzales CR. Pegaptanib sodium for macular edema secondary to branch retinal vein occlusion. Am J Ophthalmol 2010;149(1):147-154.


Efficacy of Intravitreal Bevacizumab Injection for Central Serous Chorioretinopathy

In this retrospective case series, investigators evaluated the effectiveness of intravitreal injection of bevacizmab for the treatment of central serous chorioretinopathy and found that intravitreal bevacizumab injections resulted in improved visual acuity and anatomical results for central serous chorioretinopathy.

They treated six patients (six eyes) with central serous chorioretinopathy with an intravitreal injection of bevacizumab. Outcome measures included visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) letters, central macular thickness measurement with optical coherence tomography (OCT), changes in fluorescein angiography and indocyanine green angiography.

The mean age of the patients was 42.3 years and the mean follow-up period was 9.0 months range, 5–12 months). According to the investigators, mean visual acuity ± standard deviation increased from 40.8 – 8.3 ETDRS letters at baseline to 49.0 ± 5.0 ETDRS letters at 1 month (p=0.046) and to 53.3 ± 5.2 ETDRS letters at 3 months (p=0.028). Furthermore, mean central macular thickness ± standard deviation decreased from 331.5 ± 93.4 µm to 164 ± 34 µm at 3 months (p=0.043). Leakage on fluorescein angiography and hyperpermeability on indocyanine green angiography decreased in conjunction with improvement in central macular thickness observed by OCT.

Source: Lim SJ, Roh MI, Kwon OW. Intravitreal bevacizumab injection for central serous chorioretinopathy. Retina 2010;30(1):100-106.


Central Retinal Function and Structure in RP

Using static chromatic perimetry, researchers studied patients with simplex, multiplex or autosomal recessive retinitis pigmentosa (RP, n=238; ages 9 to 82) to determine whether normal central retinal function and structure (as recently found in forms of Usher syndrome) also occur in a population of patients with nonsyndromic RP.

They evaluated a subset with optical coherence tomography (OCT) and measured co-localized visual sensitivity and photoreceptor nuclear layer thickness across the central retina to establish the relationship of function and structure. Finally, they made comparisons to patients with Usher syndrome (n=83, ages 10–69).

According to the researchers, cross-sectional psychophysical data identified patients with RP who had normal rod- and cone-mediated function in the central retina. There were two other patterns with greater dysfunction, and longitudinal data confirmed that progression can occur from normal rod and cone function to cone-only central islands. They reported that the retinal extent of normal laminar architecture by OCT corresponded to the extent of normal visual function in patients with RP and that central retinal preservation of normal function and structure did not show a relationship with age or retained peripheral function. Additionally, the study researchers noted that Usher syndrome results were like those in nonsyndromic RP.

While regional disease variation is a well-known finding in RP, the researchers in this study did not expect to see patients with presumed recessive RP with regions of functionally and structurally normal retina. They concluded that such patients will require special consideration in future clinical trials of either focal or systemic treatment. Whether there is a common molecular mechanism shared by forms of RP with normal regions of retina warrants further study.

Source: Jacobson SG, Roman AJ, Aleman TS, et al. Normal central retinal function and structure preserved in retinitis pigmentosa. Invest Ophthalmol Vis Sci 2010;51(2):1079-1085.


Macular Pigment Optical Density and Serum Lutein in RP

To determine whether macular pigment optical density (MPOD) is related to serum lutein or serum zeaxanthin in patients with retinitis pigmentosa (RP), MPOD was measured with heterochromatic flicker photometry, serum lutein and serum zeaxanthin by high-performance liquid chromatography and central foveal retinal thickness by optical coherence tomography (OCT) in 176 patients (age range, 18–68 years) with typical forms of RP. Of these patients, 37 (21%) had cystoid macular edema (CME) by OCT. Additionally, multiple regression analysis was performed with MPOD as the dependent variable and with loge serum lutein and log3 serum zeaxanthin as independent variables adjusting for age, sex, iris color, central foveal retinal thickness and, in some analyses, serum total cholesterol.

It was noted that MPOD increased with rising serum lutein (p=0.0017) and decreased with rising serum total cholesterol (p=0.0025), but was unrelated to serum zeaxanthin. Furthermore, MPOD was higher in patients with brown irides than in patients with lighter irides (p=0.014) and was nonmonotonically related to central retinal thickness (p<0.0001), being lower in eyes with more photoreceptor cell loss and in eyes with moderate to marked CME.

MPOD was found to be independently related to serum lutein, serum total cholesterol, iris color and central foveal retinal thickness in patients with retinitis pigmentosa.

Source: Sandberg MA, Johnson EJ, Berson EL. The relationship of macular pigment optical density to serum lutein in retinitis pigmentosa. Invest Ophthalmol Vis Sci 2010;51(2):1086-1091.


Seven-Year Refractive Status of Laser-Treated Threshold ROP

Investigators in China assessed the long-term visual outcomes and refractive status in patients with diode laser-treated threshold retinopathy of prematurity (ROP) and investigated the causes of impaired visual function. They found that the majority of patients with diode laser-treated threshold ROP had favorable anatomical and visual outcomes.

A total of 60 eyes of 30 consecutive patients with diode laser-treated threshold ROP were recalled for assessment at the age of 7 years or more. While the investigators reported that 38 eyes (65.5%) achieved 6/12 or better vision, they also noted that an unfavorable visual outcome (6/60 or worse) occurred in four eyes (6.9%). In addition, one eye (1.7%) had unfavorable structural outcome. Of the 60 laser-treated eyes, 46 (77.0%) were myopic and the overall mean spherical equivalent was -3.87D. The investigators also noted anisometropia (1.5D) in 14 patients (46.7%) and strabismus in nine (30.0%) patients. Furthermore, they identified perinatal neurological events of intraventricular hemorrhage (IVH) in eight children (26.7%), periventricular leucomalacia (PVL) in eight children (26.7%) and cerebral palsy (CP) in four children (13.3%). There was a statistically significant association of the presence of strabismus with PVL (p=0.002) and the presence of anisometropia was a significant risk factor associated with poor visual outcome of 6/15 or worse in laser-treated ROP (p=0.002).

The investigators in this study concluded that anisometropia, advanced refractive error, strabismus and perinatal neurological events remain important causes of impaired visual function and that long-term follow up is very important for the early detection and timely treatment of these ocular morbidities.

Source: Yang CS, Wang AG, Sung CS, et al. Long-term visual outcomes of laser-treated threshold retinopathy of prematurity: a study of refractive status at 7 years. Eye 2010;24(1):14-20.


An Evaluation of RNFL Thickness in Various Populations

The authors of this study evaluated the retinal nerve fiber layer (RNFL) profile of healthy controls, persons with exfoliation syndrome (XFS) and patients with exfoliation glaucoma (XFG) and primary open-angle glaucoma (POAG).

They analyzed one eye from each of 269 participants. Of these, 50 were normal, 45 had XFS, 89 had POAG and 89 had XFG. The study authors divided the glaucoma patients according to the severity of the disease into mild and advanced groups. They reported that all participants underwent imaging with the GDx-VCC device and performed measurements of the parameters TSNIT average, TSNIT SD and nerve fiber indicator (NFI). The authors also compared RNFL thickness values by means of Bonferroni-corrected t-tests.

Regarding control and glaucoma groups, the authors identified statistically significant differences in all GDx parameters. RNFL thickness values of the control group differed significantly from the values of the XFS group and there was no statistically significant difference between RNFL thickness values for the mild POAG and mild XFG groups or for the advanced POAG and advanced XFG groups.

The authors of this study determined that polarimetry-determined RNFL in eyes with XFS is thinner than that of healthy eyes. Additionally, they found no differences in RNFL thickness when they compared eyes with POAG and XFG of similar severity.

Source: Kozobolis VP, Glynatsis M, Labiris G, et al. Retinal nerve fiber layer thickness in patients with exfoliation, exfoliative glaucoma, and primary open-angle glaucoma. Eur J Ophthalmol 2010;20(1):142-148.






OD-OS, Inc. Appoints Falzon as COO and President

Developer of Navigated Retina Laser Therapy, OD-OS, has announced the appointment of Peter Falzon as Chief Commercial Officer of OD-OS and President of OD-OS, Inc. In his new role, Mr. Falzon will lead the global market introduction of the NAVILAS retina navigation therapy solution as well as the U.S. business for OD-OS. Mr. Falzon bring to his new role the experience of former posts at such companies as Osyris Medical; Ellex Medical; Cutera, Inc.; and Coherent, Inc.

Source: OD-OS, Inc. February 2010.



New SLT Lens from Volk Provides Clear Chamber Angle Views

Volk Optical's new SLT Lens is tailored to the needs of selective laser trabeculoplasty procedures and provides detailed, high-resolution views of the anterior chamber angle for examination and laser spot placement. The company states that the SLT's single internally reflecting surface, which is the preferred standard for SLT procedures, delivers 1.0x magnification, maintaining laser spot size and power density. Its curved upper lens surface ensures the laser beam profile remains circular for consistent spot placement and the contact lens design, used with a coupling fluid, provides stability for laser delivery, making the SLT Lens suitable for all laser trabeculoplasty procedures. To learn more, click here.

Source: Volk Optical Inc., January 2010.




Ellex to Offer Integrated Yellow Laser

Ellex Medical Lasers Limited recently announced the launch of a new yellow laser photocoagulator, Integre Yellow. The Integre Yellow is the first and only laser system to offer high-power 561 nm yellow in a unique, fully integrated design, says Ellex. The fully integrated design of the Integre Yellow provides improved working distance and ergonomics to optimize practice efficiency and completely eliminates the need for external adapters or fibers. The company launched its new yellow laser photocoagulator at the 33rd Annual Meeting of the Japanese Society of Ophthalmic Surgeons in Tokyo and plans to launch it in the United States, Europe and Australia later in 2010.

Source: Ellex Medical Lasers Limited, January 2010.





 

 

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