Ranibizumab or Bevacizumab for Neovascular Age-Related Macular Degeneration According to the Lucentis Compared to Avastin Study Treat-and-Extend Protocol: Two-Year Results.

PURPOSE: To compare the efficacy and safety of bevacizumab (Avastin; F. Hoffmann-La Roche Ltd, Basel, Switzerland) versus ranibizumab (Lucentis; Novartis Pharma AG, Basel, Switzerland) for neovascular age-related macular degeneration (nAMD) after 2 years when using a treat-and-extend protocol. DESIGN: Multicenter, randomized, noninferiority trial with a noninferiority limit of 5 letters. PARTICIPANTS: Patients 50 years of age or older with previously untreated nAMD in 1 eye and best-corrected visual acuity 20/25 to 20/320. METHODS: Patients were assigned randomly to receive intravitreal injections with either ranibizumab 0.5 mg or bevacizumab 1.25 mg. Injections were given every 4 weeks until inactive disease was achieved. The treatment interval then was extended by 2 weeks at a time up to a maximum of 12 weeks. In the event of a recurrence, the treatment interval was shortened by 2 weeks at a time. MAIN OUTCOME MEASURE: Mean change in visual acuity at 2 years. RESULTS: Of a total of 441 randomized patients, 339 patients (79%) completed the 2-year visit. According to per-protocol analysis at 2 years, bevacizumab was equivalent to ranibizumab, with 7.4 and 6.6 letters gained, respectively (95% confidence interval [CI] of mean difference, -4.1 to 2.5; P = 0.634). Intention-to-treat analysis was concordant, with a gain of 7.8 letters for bevacizumab and 7.5 letters for ranibizumab (95% CI of mean difference, -3.2 to 2.7; P = 0.873). The 2-year results did not show any significant difference in mean central retinal thickness, with a decrease of -113 µm for bevacizumab and -122 µm for ranibizumab (95% CI of mean difference, -32 to 15; P = 0.476). There was a statistically significant difference between the drugs regarding the number of treatments given, with 18.2 injections for bevacizumab and 16.0 injections for ranibizumab (95% CI of mean difference, -3.4 to -1.0; P ≤ 0.001). The number of serious adverse events was similar between the groups over the course of the study. CONCLUSIONS: At 2 years, bevacizumab and ranibizumab had an equivalent effect on visual acuity and reduction of central retinal thickness when administered according to a treat-and-extend protocol for nAMD. There was no significant difference in the number of serious adverse events between the treatment groups.

Efficacy of ranibizumab in patients with macular edema secondary to central retinal vein occlusion: results from the sham-controlled ROCC study.

PURPOSE: The ROCC study (randomized study comparing ranibizumab to sham in patients with macular edema secondary to central Retinal vein OCClusion [CRVO]) evaluated the short-term effect of intravitreal ranibizumab injections on best-corrected visual acuity (BCVA) and macular edema. DESIGN: Prospective, multicenter, randomized, double-masked, placebo-controlled trial. METHODS: In this 6-month trial, 32 patients with macular edema secondary to CRVO were randomized to receive monthly intravitreal ranibizumab (0.5 mg/0.05 mL) or sham injections for 3 consecutive months. If macular edema persisted, patients received further monthly injections. Primary outcome measures were BCVA and central macular thickness (CMT) at 6 months. RESULTS: Twenty-nine patients completed the study. After 3 months, BCVA improved by a mean +/- standard deviation (SD) of 16 +/- 14 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the ranibizumab group (n = 15), compared with a mean loss of 5 +/- 15 ETDRS letters in the sham group (n = 14; P = .001). The mean +/- SD change in CMT was -411 +/- 200 microm in the ranibizumab group and -86 +/- 165 microm with sham (P < .001). At 6 months, the mean +/- SD change in BCVA was 12 +/- 20 ETDRS letters in the ranibizumab group compared with -1 +/- 17 ETDRS letters in the sham group (P = .067). The mean +/- SD change in CMT was -304 +/- 194 microm with ranibizumab and -151 +/- 205 microm with sham (P = .05). Twelve patients (80%) in the ranibizumab group required more than 3 initial injections; mean +/- SD number of injections was 4.3 +/- 0.9 during the study. CONCLUSION: Monthly ranibizumab significantly increased BCVA and decreased macular edema, compared with sham, in patients with CRVO. Repeated consecutive injections are necessary to maintain initial positive results.

Retinal artery occlusion following intravitreal anti-VEGF therapy.

PURPOSE: Anti-vascular endothelial growth factor (anti-VEGF) therapy effectively inhibits angiogenesis and is now enjoying widespread use in the treatment of age-related macular degeneration (AMD). It may also have a role in the treatment of macular oedema secondary to other conditions. VEGF is a signalling molecule that has a variety of roles, including vasoregulation and effects on the coagulation homeostasis. Anti-VEGF therapy may therefore have adverse effects on ocular blood flow. METHODS: Two cases of retinal artery occlusion after intravitreal injection of anti-VEGF are presented. Both patients were given the treatment to reduce macular oedema secondary to central retinal vein occlusion. Possible mechanisms are discussed. RESULTS: Patient 1 developed a central retinal artery occlusion within 1 month of an intravitreal injection of ranibizumab (Lucentis). The macular oedema was totally resolved at 1 month; final visual acuity (VA) was light perception. Patient 2 developed a branch retinal artery occlusion in the macula 2 days after an intravitreal injection of bevacizumab (Avastin). The macular oedema was almost resolved within 1 week and did not recur; final VA was 0.6. CONCLUSIONS: Anti-VEGF therapy may have a role in the treatment of macular oedema caused by central retinal vein occlusions. However, our report indicates that the therapeutic principle may be associated with an increased risk of retinal arterial occlusions.

The prevalence of age-related maculopathy (ARM) in an urban Norwegian population: the Oslo Macular study.

PURPOSE: To examine the prevalence of early and late age-related maculopathy (ARM) in citizens aged 51 years and older in the city of Oslo and its surroundings. METHODS: We selected a random sample of 800 subjects, using a cross-sectional study design. A total of 459 of the 770 eligible subjects agreed to participate, giving an attendance rate of 59.6%. Stereoscopic colour digital photographs were obtained and graded at a certified reading centre using the International Classification Grading System for ARM. RESULTS: Early ARM in either eye was found in 43.1% (95% CI 38.5-47.7) of subjects aged 51 years and older. This was due to a much higher prevalence of pigmentary changes, predominantly hyperpigmentation in all age groups, than previously reported; 37.5% of people aged 51-60 years of age had pigmentary changes > or = 63 microm, increasing to 66.0% in the oldest age group. In people aged 71 years and older, geographic atrophy (GA) was found in either eye in 3.6% (95% CI 0.4-6.8) and exudative macular degeneration (AMD) was found in either eye in 2.9% (95% CI 0.0-5.7) of subjects. CONCLUSION: To our knowledge, this is the first published study to rely solely on digital photography for grading purposes in a population-based study. Early ARM was found to have a higher prevalence than previously reported in other populations. Exudative AMD and GA had similar prevalences to those described in the literature, although the prevalence of GA tended to be higher than previously reported in some surveys.

[Age Related Macular Degeneration--a review]. / Hrörnun í augnbotnum--yfirlit.

Age-Related Macular Degeneration is the leading cause of legal blindness in elderly people in Iceland as well as in the western world. If not addressed this will have a huge impact on the quality of life in the ever increasing elderly population. The etiology remains unknown inspite of a better understanding of the pathogenesis. Our treatment options have therefore been limited in the past. For the last few years we have seen a certain progress in drug development and introduction of new drugs into the treatment regime which have reduced severe vision loss somewhat and increased quality of life for these patients. It has also given hope for better treatments to come, which ultimately will be able to stop the disease completely or even prevent it.

[Prevalence of refractive errors in Norway]. / Prevalens av brytningsfeil i Norge.

BACKGROUND: The aim of this study was to determine the prevalence of refractive errors among young and middle-aged adults in Norway. MATERIAL AND METHODS: Refractive errors were measured with an autorefractor in a population-based sample of young (20-25 years) and middle-aged (40-45 years) adults participating in a health study (HUNT) conducted in Nord-Trøndelag county in Norway in 1996-97. RESULTS: A total of 3137 persons (1248 young and 1889 middle-aged adults) with corrected visual acuity >0.5 (in either eye) were included. About half of the population (51.8% among the young and 52.3% among the middle-aged adults) were emmetropic. The prevalence of myopia was 35.0% in the young adult group and 30.3% in the middle-aged group. Myopia was significantly higher in women aged 20-25 years (36.4%) than in men aged 40-45 years (28.1%). Prevalence of hyperopia increased with age from 13.2% (20-25 years) to 17.4% (40-45 years). INTERPRETATION: The results show a relative high prevalence of myopia in the general population of Norway.

[Retinoblastoma--hereditary eye cancer in children]. / Retinoblastom--arvelig øyekreft hos barn.

BACKGROUND: Retinoblastoma is a malignant tumour of the retina that occurs in early childhood. The aim of this paper is to give an updated review of the disease. MATERIAL AND METHODS: A review is given based on literature published over the last few years and on the authors' own experience. RESULTS: The yearly incidence of retinoblastoma is approximately one per 14 000 live births, which gives four new cases of retinoblastoma per year in Norway. The only known risk factor is heritage. Symptoms of retinoblastoma are strabismus, reduced visual acuity and red eye, but the absolutely most important sign is leukokoria (white pupillary reflex). Important diagnostic tools are ophthalmoscopy, ultrasonography, CT and MRI. The goal of treatment is to destroy all tumour tissue, but not the surrounding tissue. Treatment options are enucleation, chemotherapy, external beam radiation, radioactive isotope plaques, cryotherapy, photocoagulation, or a combination of these depending upon the size and location of the tumour. INTERPRETATION: The overall results in the treatment of retinoblastoma are favourable and have improved over the last few years because of better treatment modalities. The survival rate is approximately 95%. It is important that physicians bear in mind the signs of retinoblastoma and especially the alarming sign of leukokoria and acute strabismus in a child.

Prevalence of refractive errors in young and middle-aged adults in Norway.

PURPOSE: To determine the prevalence of refractive errors in the young and middle-aged adult population in Norway. METHODS: Refractive errors were measured in a population-based sample of young (20-25 years) and middle-aged (40-45 years) adults participating in the Helseundersøkelse i Nord Trøndelag (HUNT) Health Study, conducted in the County of Nord-Trøndelag in Norway. RESULTS: A total of 3137 persons (1248 young and 1889 middle-aged adults) with corrected visual acuity > or = 0.5 (in either eye) were included in the study. The prevalence of myopia was 35.0% in the young adult group and 30.3% in the middle-aged group. Myopia was significantly higher in women aged 20-25 years (36.4%) than in men aged 40-45 years (28.1%). Prevalence of hyperopia increased with age from 13.2% (20-25 years) to 17.4% (40-45 years). The highest rate of hyperopia (20.1%) was encountered in middle-aged women. CONCLUSION: The results show a slightly higher prevalence of myopia in the general population of Norway than previously estimated.