Volume 3, Number 12
December 2007



Contents:
WELCOME
THE LATEST PUBLISHED RESEARCH
NOTEWORTHY: U.S. SENATOR INVESTIGATES GENENTECH’S DECISION ON BEVACIZUMAB; FDA APPROVES INJECTABLE TRIAMCINOLONE SUSPENSION; AND OTHER ITEMS OF INTEREST






WELCOME

Welcome to Review of Ophthalmology’s Retina Online 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.

In this edition:
The latest published research
Noteworthy, items of interest

Table of Contents





THE LATEST PUBLISHED RESEARCH

Endophthalmitis Following 25-Ga. vs. 20-Ga. Vitrectomy
In a retrospective, interventional, comparative cohort study involving 8,601 consecutive pars plana vitrectomy patients, those who underwent a 25-ga. procedure had a 12-fold higher incidence of endophthalmitis compared with those who underwent a 20-ga. procedure (p=0.004). The vitrectomies were performed at a single center between Jan. 1, 2004 and Sept. 1, 2006.

Endophthalmitis developed in onr of 5,498 eyes after 20-ga. vitrectomy (0.018 percent) and in 7 of 3,103 eyes after 25-ga. vitrectomy (0.23 percent). The authors of the study paper also noted that visual outcomes of vitrectomy-associated endophthalmitis was poor for both 20-ga. and 25-ga. vitrectomy. Median final visual acuity for all cases of endophthalmitis was counting fingers or hand movements (20/50 to no light perception).

Source: Kunimoto DY, Kaiser RS. Incidence of endophthalmitis after 20- and 25-gauge vitrectomy. Ophthalmology 2007;114:2133-2137.


Triamcinolone Plus PDT vs. PDT Alone for Wet AMD
In a single-center, prospective pilot clinical study, 30 eyes of 30 patients with occult or minimally classic choroidal neovascularization (CNV) secondary to age-related macular degeneration were randomized to treatment with either verteporfin (Visudyne) photodynamic therapy or PDT plus intravitreal triamcinolone acetonide. Standard PDT was performed in all patients; patients in the combination treatment group received a 12-mg injection of triamcinolone 30 minutes after PDT. Active lesions were retreated every three months for one year.

At one year, mean visual acuity remained stable in the combination group (-1.9 letters, p=0.58) but declined significantly in the monotherapy group (-13.3 letters, p=0.02). The treatment rate was 1.13 in the combination group and 3.6 in the monotherapy group (p<0.0001). Mean contrast sensitivity increased in the combination group and decreased in the monotherapy group.

Cataracts progressed in four of seven phakic eyes in the combination treatment group. Six patients in that group (40 percent) required topical therapy to control elevated intraocular pressure.

Source: Chaudhary V, Mao A, Hooper PL, Sheidow TG. Triamcinolone acetonide as adjunctive treatment to verteporfin in neovascular age-related macular degeneration: a prospective randomized trial. Ophthalmology 2007;114:2183-2189.


One-Year Subgroup Analysis from ANCHOR Trial of Ranibizumab
Results of the retrospective subgroup analysis of 12-month data from the ANCHOR study comparing ranibizumab (Lucentis) with verteporfin PDT for the treatment of predominantly classic CNV secondary to AMD have been published. Investigators used univariate analyses to assess visual acuity outcomes across subgroups based on patient gender and baseline age, visual acuity, lesion size and type, and duration of neovascular AMD. They used multivariate analyses to identify predictors of visual acuity change from baseline to 12 months.

On average, all subgroups treated with ranibizumab experienced better outcomes than patients treated with PDT for all three visual acuity outcome measures (proportion losing <15 letters from baseline, proportion gaining ≥15 letters from baseline, mean change from baseline). Lower baseline visual acuity, smaller baseline CNV lesion size and younger baseline age were associated with greater gain of letters with ranibizumab treatment and less loss of letters with PDT. Results of this analysis were consistent with the subgroup analysis of 24-month data from the Phase III MARINA trial of ranibizumab.

Sources: Kaiser PK, Brown DM, Zhang K, et al. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol 2007;144:850-857.


Micropulsed Laser and Triamcinolone Successful for Treatment of RAP
Based on their retrospective, noncomparative, interventional, consecutive case series, a group of investigators concluded that micropulsed laser photocoagulation and intravitreal injection of triamcinolone acetonide may be a safe and effective treatment for retinal angiomatous proliferation (RAP) lesions. Fourteen eyes of 13 patients were treated for RAP by one of four retina specialists at a single center. Yellow or green dye was used in the photocoagulation, which was delivered for 0.02 to 0.05 seconds. Laser power was adjusted to create a white burn of moderate intensity at the level of the lesion in the retina. A triamcinolone injection of 4 mg/0.1 mL preceded laser treatment by a median of seven days in eight eyes, was performed on the same day in two eyes, and followed laser treatment by a median of seven days in four eyes. Patients were followed for a median of 18 months (12 to 27 months).

At 12 months and the last follow-up visit, visual acuity stabilized in five eyes (36 percent), improved by two or more lines in six eyes (43 percent), and worsened by two or more lines in three eyes (21 percent). Median visual acuity before treatment was 20/200 compared with 20/200 at 12 months after treatment (p=0.73) and 20/100 at the last follow-up visit (p=0.63). Fluorescein angiography at six months after both treatments showed resolution of all leakage in 13 eyes (93 percent.

One eye received verteporfin PDT six months after treatment for persistent low-grade leakage. Intraocular pressure greater than 25 mmHg occurred in two eyes at 2.5 months and two months after triamcinolone injection; both eyes were treated with transient use of antiglaucoma eyedrops. Cataracts progressed in seven of nine phakic eyes (78 percent); five of the seven underwent cataract extraction during the follow-up period.

Source: Roth DB, Scott IU, Gloth JM, et al. Micropulsed laser photocoagulation and intravitreal triamcinolone acetonide injection for the treatment of retinal angiomatous proliferation. Retina 2007;27:1201-1204.


Prospective, Randomized Study Compares Scleral Buckling with Primary PPV for Rhegmatogenous Retinal Detachment
A prospective, randomized clinical study comparing scleral buckling with primary pars plana vitrectomy for rhegmatogenous retinal detachments of medium complexity showed SB to provide a visual acuity benefit in phakic eyes. For pseudophakic eyes, based on a finding of better anatomical outcome, the authors of the study paper recommended PPV. The study involved 45 surgeons at 25 centers in five European countries, 416 phakic eyes and 265 pseudophakic eyes. Patients were enrolled over five years, and outcomes were assessed at one year. Completion of follow-up was achieved in 93 percent of the phakic group and 89 percent of the pseudophakic group.

In phakic eyes, change in mean best-corrected visual acuity was significantly greater in the SB group (-0.71 logMAR vs. -0.56 logMAR, p=0.0005). Also in phakic eyes, cataract progression was greater in the PPV group (p<0.00005). In pseudophakic eyes, the primary anatomical success rate (retinal reattachment without any secondary retina-affecting surgery) was significantly better (p=0.0020) in the PPV group. In phakic eyes, redetachment rates were 26.3 percent for SB and 25.1 percent for PPV. In pseudophakic eyes, redetachment rates were 39.8 percent for SB and 20.4 percent for PPV.

Source: Heimann H, Bartz-Schmidt KU, Bornfeld N, et al. Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment: a prospective randomized multicenter clinical study. Ophthalmology 2007;114:2142-2154.

Comparison of Treatments for Macular Edema Due to BRVO
In a retrospective evaluation of posterior subtenon triamcinolone (PSTT), intravitreal triamcinolone (IVT) and grid laser photocoagulation (GLP) in eyes with macular edema secondary to branch retinal vein occlusion, IVT and GLP appeared to be more effective than PSTT at three months.

In the PSTT group (20 eyes), mean visual acuity and central foveal thickness were 0.23 +/-0.23 and 413.2 +/-143.5 µm before treatment and 0.23 +/-0.18 and 358.7 +/-109.2 µm at month three (p=0.504, p=0.031). In the IVT group (35 eyes) mean visual acuity increased from 0.14 +/-0.15 to 0.33 +/-0.26 and the mean central foveal thickness decreased from 518.2 +/-145 µm to 292.9 +/-121 µm at month three (p=0.001). In the GLP group (24 eyes), mean visual acuity increased from 0.29 +/-0.25 to 0.47 +/-0.32 (p=0.001) and central foveal thickness decreased from 397.3 +/-105.9 µm to 307.1 +/-88.4 µm at month three (p=0.005).

The authors of the study reported that visual acuity and central foveal thickness changes were significantly different between the groups at month three (p=0.031); visual acuity increase was significantly greater in the IVT group than in the PSTT group; and decrease in central foveal thickness was highest in the IVT group (p=0.001). They also noted that potential complications of IVT and GLP should be weighed against their advantages for each patient.

Source: Ozdek S, Deren YT, Gurelik G, Hasanreisoglu B. Posterior subtenon triamcinolone, intravitreal triamcinolone and grid laser photocoagulation for the treatment of macular edema in branch retinal vein occlusion. Ophthalmic Res 2008;40:26-31 (DOI: 10.1159/000111155).

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NOTEWORTHY: U.S. SENATOR INVESTIGATES GENENTECH’S DECISION ON BEVACIZUMAB; FDA APPROVES INJECTABLE TRIAMCINOLONE SUSPENSION; AND OTHER ITEMS OF INTEREST

U.S. Senator Investigates Genentech’s Decision on Bevacizumab
Sen. Herb Kohl (D-Wis.), chairman of the U.S. Senate Special Committee on Aging, has begun investigating the decision by Genentech to stop making bevacizumab (Avastin) available to compounding pharmacies effective Jan. 1, 2008. Sen. Kohl sent a letter on Oct. 18 to Kerry Weems, acting administrator of the Centers for Medicare & Medicaid Services, inquiring about the decision’s cost implications. He also sent a letter on Nov. 7 to FDA Commissioner Andrew C. von Eschenbach, MD, requesting documents and information pertaining to the agency’s recent interactions with Genentech.

Sen. Kohl sent a second letter on Nov. 14 to Dr. von Eschenbach, requesting additional information, including a recent FDA Establishment Inspection Report covering Genentech’s San Francisco facility and whether as part of that inspection the agency instructed the company to destroy four lots of Avastin and whether those lots could have been used for nonocular, i.e., cancer-related purposes. "The company claims to have suffered a substantial financial write-off due to what it understood to be FDA’s instructions or concerns about the Avastin lots in question," the letter stated. He also asked that the agency provide the committee with clarification of the FDA’s official position regarding Genentech supplying bevacizumab to compounding pharmacies.

In addition, Sen. Kohl sent a letter on Nov. 16 to Susan Desmond-Hellman, MD, MPH, president of product development for Genentech. In that letter, he stated his concerns, based on an Oct. 12 Wall Street Journal article, that Genentech’s decision could cost taxpayers as much as $3 billion. He asked that the company provide him with any and all documentation of discussions it had with government or private sponsors related to the CATT study comparing bevacizumab to ranibizumab, any internal records, minutes or notes regarding its decision on bevacizumab and compounding pharmacies, any documentation regarding its decision to require purchasing contracts for some bevacizumab customers, and documentation surrounding its sending of a letter to patients warning them about off-label use of bevacizumab.

Source: www.aging.senate.gov/letters/genentechltr.pdf and www.aging.senate.gov/letters/genentechfdaltr2.pdf.


FDA Approves Injectable Triamcinolone Suspension
The FDA approved Alcon’s triamcinolone acetonide injectable suspension (Triesence 40 mg/mL), a preservative-free synthetic corticosteroid. Triesence is indicated for aiding in visualization during vitrectomy and for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.

Source: Alcon, November 2007.


One-Year Data Presented on New Radiation Treatment for Wet AMD
NeoVista Inc., released new data from an ongoing, nonrandomized, multicenter, one-year feasibility study of its beta radiation epiretinal therapy for neovascular AMD. In the study, the therapy is used in combination with intravitreal bevacizumab. Patients in the study (n=34) had predominantly classic, minimally classic or occult (with no classic) CNV and received a single 24 Gy treatment of the epiretinal therapy in combination with two injections of bevacizumab: one dose at the time of radiation delivery and another one month later.

After 12 months follow-up, mean ETDRS visual acuity improved by 13.1 letters. A total of 96 percent of patients lost less than 15 letters of visual acuity; 15 percent required additional injections of bevacizumab throughout the year; and 12 percent experienced adverse events related to the procedure (retinal tear, retinal detachment, subretinal hemorrhage or vitreous hemorrhage).

Unlike previous forms of radiation therapy for wet AMD, the NeoVista technique delivers the peak dose of radiation directly to the lesion without damaging the underlying choroidal vasculature. Utilizing strontium-90, the focused radiation is delivered to a target area 3 mm deep and up to 5.4 mm in diameter. The effective dose of radiation to the entire body from is comparable to 15 minutes of exposure to the sun.

For more information, visit neovistainc.com.

Source: NeoVista Inc., November 2007.


Initial Clinical Results Released on Nonthermal Laser Treatment for DME
Initial clinical results from an ongoing study of Retina Regeneration Therapy (2RT, Ellex Medical Lasers Ltd.) suggested that it can improve or stabilize vision and reduce retinal edema in patients with diabetic maculopathy and diabetic macular edema without damaging photoreceptors. The prospective 12-month study, which included 18 patients (29 eyes), evaluated the effectiveness of selective retinal pigment epithelium treatment with a nonthermal laser. Patient follow-up occurred at three, six and 12 months post-op. All patients received treatments with Ellex 2RT prototype lasers developed specifically for this research program.

At three months, the majority of patients experienced improvement in visual acuity and central macular thickness as measured by optical coherence tomography. Central macular thickness decreased in 55 percent of eyes and remained stable in 24 percent; it increased in 20 percent of eyes. Microperimetry confirmed no evidence of laser damage to the photoreceptor cells. Clinical trials for the therapy will begin in Australia and will be conducted in multiple centers internationally over the next year.

For more information, visit ellex.com.

Source: Ellex Medical Lasers Ltd., November 2007.

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