Ranibizumab for the treatment of diabetic macular oedema

Ranibizumab for the treatment of diabetic macular edema

National Institute for Health and Clinical Excellence

Nice

Additional information published in 2012

Diabetic Macular Edema Responds Best to Frequent Ranibizumab

Medscape Medical News

Clinical Applications of Cost Analysis of Diabetic Macular Edema Treatments.

Oct 2012

Smiddy WE.

Source

Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: wsmiddy@med.miami.edu.

Abstract

OBJECTIVE:

To apply cost-benefit analyses in specific circumstances in which the results of multiple modalities of treating diabetic macular edema (DME) are similar, as a basis for considering economic ramifications in clinically relevant applications.

DESIGN:

A model of resource use, outcomes, and cost-effectiveness and utility.

PARTICIPANTS:

There were no participants.

METHODS:

Results from published clinical trials (index studies) of laser, intravitreal corticosteroids, intravitreal anti-vascular endothelial growth factor (VEGF) agents, and vitrectomy trials were used to ascertain visual benefit and clinical protocols of patients with DME. Calculations followed from the costs of 1 year of treatment for each modality and the visual benefits as ascertained.

MAIN OUTCOME MEASURES:

Visual acuity (VA) saved, cost of therapy, cost per line saved, cost per line-year saved, and costs per quality-adjusted life years (QALYs) saved.

RESULTS:

Four specific situations were observed or analyzed: (1) Treatment results for DME causing VA loss less then twenty over two hundred. at least as much visual benefit for intravitreal triamcinolone versus laser; a subgroup analysis of pseudophakic DME eyes shows equivalent visual results with anti-VEGF treatment versus laser combined with IVTA, eyes with VA of greater then or equal to twenty over thirty two,  have been studied only by laser; and (4) less frequent use of aflibercept yields equivalent visual results as more frequent treatment. When the results are equivalent, opting for the less-expensive treatment option could yield cost savings of forty percent to eighty eight percent..

CONCLUSIONS:

Cost-effectiveness analyses can be clinically relevant and may be considered when formulating and applying treatment strategies for some subsets of patients with DME.

Elsevier

Ranibizumab: in diabetic macular oedema.

Mar 2012

Frampton JE.

Source

Adis, Auckland, New Zealand.

Abstract

Ranibizumab, an intravitreally administered inhibitor of vascular endothelial growth factor (VEGF), is approved for the treatment of visual impairment associated with diabetic macular oedema (DME) in the EU. In four well designed, phase II or III trials (RESOLVE, RESTORE, RIDE and RISE), 1-2 years' treatment with ranibizumab was more effective than sham or focal/grid laser therapy in improving best corrected visual acuity (BCVA) and reducing central retinal thickness (CRT) in patients with visual impairment associated with DME. Additionally, in two well designed phase III trials (RESTORE and DRCR.net-1), 1 year of treatment with ranibizumab as an adjunct to laser therapy was more effective than laser monotherapy in improving BCVA and CRT in patients with visual impairment associated with DME. Improvements in BCVA with ranibizumab alone or as an adjunct to laser therapy were observed at the first follow-up visits in these studies (i.e. 1-4 weeks after the start of treatment), and were associated with gains in vision-related quality of life, as assessed using the National Eye Institute Visual Functioning Questionnaire-25. The ocular and non-ocular adverse event profile of ranibizumab in patients with DME is similar to that observed in patients with neovascular (wet) age-related macular degeneration or retinal vein occlusion. Based on tolerability data from clinical trials, there is no indication that ranibizumab alone or combined with laser is associated with an increased risk of cardiovascular or cerebrovascular events potentially related to systemic VEGF inhibition.

PubMed

Efficacy of intravitreal bevacizumab (Avastin) for short-term treatment of diabetic macular edema.

Efficacy of intravitreal bevacizumab (Avastin) for short-term treatment of diabetic macular edema.
Nagasawa T, Naito T, Matsushita S, Sato H, Katome T, Shiota H.
Department of Ophthalmology, Institute of Health Biosciences, the University of Tokushima Graduate School, Tokushima, Japan.

PURPOSE: To report the efficacy of intravitreal injections of bevacizumab for diabetic macular edema (DME) in the short-term.

DESIGN: Retrospective, noncomparative, interventional case series.

METHODS: Medical records of 20 eyes of 19 patients who underwent intravitreal injections of bevacizumab for persistent diabetic macular edema were reviewed retrospectively. All eyes received intravitreal injections of bevacizumab (1.25 mg/0.05 ml). The clinical course of best-corrected visual acuity (BCVA) using a logarithm of the minimum angle of resolution chart, and averaged foveal retinal thickness using an optical coherence tomography (OCT) were monitored for up to four weeks after the injection.

RESULTS: BCVA at one week improved by two lines or more in six eyes (30%) and in nine eyes (45%) at four weeks. However, no significant improvement in the mean BCVA from baseline was observed at one week (P>0.05) and four weeks (P>0.05). Mean retinal thicknesses (RT) were 411+/-170 mum at baseline, 349+/-102 microm at one week after the injection (P<0.05),>0.05). One week after the injection, significant regression of macular edema was seen. However, recurrence occurred at four weeks. No complications such as severe vision loss, endophthalmitis, or systemic events developed.

CONCLUSION: No changes in BCVA and RT were observed in the short-term observation after the intravitreal injection of bevacizumab for DME.

Journal of Medical Investigation

Types of diabetic macular edema assessed by optical coherence tomography.

Types of diabetic macular edema assessed by optical coherence tomography.

Koleva-Georgieva DN, Sivkova NP.
Department of Ophthalmology, Medical University, Plovdiv, Bulgaria.

AIM: To assess the types of diabetic macular edema (DME) in patients with type 2 diabetes mellitus by analyzing retinal thickness, morphology and presence of macular traction using optical coherence tomography (OCT).

PATIENTS AND METHODS: This prospective study included 74 diabetics with diabetic retinopathy (DR) (141 eyes), 29 diabetics without DR (57 eyes) and 25 healthy volunteers (39 eyes). The ophthalmic examination included best corrected visual acuity, stereo-ophthalmoscopy, fluorescein angiography and OCT. DME assessment was based on the analysis of several OCT features: macular thickness, retinal morphology and presence of macular traction--vitreomacular and/or from epiretinal membranes. Four OCT types of DME were suggested: type 1--early, type 2--simple, type 3--cystoid (3a--mild, 3b--intermediate, 3c--severe) and type 4--serous macular detachment. The distribution of the DME types and their correlation with retinal thickness and visual acuity were analyzed.

RESULTS: The distribution of eyes with DME was: type 1--14.1%, type 2--30.4%, type 3--45.7% (3a--14.1%, 3b--12%, 3c--19.6%) and type 4--9.8%. Macular traction with retinal distortion was detected in 31.5% of the eyes with DME. Retinal thickness at the fixation point was 176 +/- 16.8 microm (116 microm / 210 microm) in healthy eyes and 182.2 +/- 19.6 microm (138 microm / 212 microm) in eyes without DR. There was no statistically significant difference between the two groups (Independent samples test, P less then 0.05). The retina was significantly thicker in eyes with early DME (232.9 plus/minus 7.9 microm) than in healthy eyes and eyes without DR (Independent samples test, F = 16.274 and F = 13.100, P less then f equals 16.692.

CONCLUSION: OCT precisely differentiated 4 types of DME: early, simple, cystoid and serous macular detachment, as well as determined the presence of macular traction. The early diagnosis, high precision in retinal thickness measurement, assessment of the morphologic types and macular traction are of uppermost importance in determining the therapeutic approach, prognosis and the effect of treatment.

PMID: 19009748 [PubMed - in process]

Bevacizumab improved vision, macular edema in study of RVO patients

Bevacizumab improved vision, macular edema in study of RVO patients

OSN SuperSite Breaking News 10/24/2007

Bevacizumab improved visual acuity and central macular edema symptoms in patients with retinal vein occlusion within 9 weeks after treatment, according to a prospective study by researchers in Germany.

Andreas Stahl, MD, and colleagues at University of Freiburg evaluated the 9-week responses to a single injection of Avastin (bevacizumab, Genentech) in 14 central retinal vein occlusion (RVO) patients and seven branch RVO patients.

At follow-up, the researchers found that mean visual acuity for the 21 patients had increased an average of 2.4 lines (P < .01) over baseline. Also, the improvement in visual acuity was in concert with a decrease in central retinal thickness, according to the study.

The best improvement in visual acuity was reached between 3 and 6 weeks post-injection and began to decrease from 6 to 9 weeks, the authors noted.

"This [visual acuity] decrease was precipitated by an increase in [central macular edema] between week 3 and 6," they said.

In subgroup analyses, patients who received a bevacizumab injection within the first 3 months of RVO showed an average four-line gain in vision, compared with an average gain of 1.8 lines in patients treated between 4 and 6 months after RVO and a gain of 2.5 lines for those treated later than 6 months after RVO onset, according to the study.

"We did not observe any short-term adverse effects during our study," the authors noted.

The study is published in the October issue of Graefe's Archive for Clinical and Experimental Ophthalmology.

The use of intravitreal etanercept in diabetic macular edema.

The use of intravitreal etanercept in diabetic macular oedema.

Semin Ophthalmol. 2007 Apr-Jun

Tsilimbaris MK, Panagiotoglou TD, Charisis SK, Anastasakis A, Krikonis TS, Christodoulakis E.
Retina Service, Department of Ophthalmology, University Hospital of Heraklion. Crete.

The aim of this pilot study was to investigate the effect of intravitreal administration of etanercept in refractory diabetic macular edema. Seven patients diagnosed with diabetic macular edema, refractory to previous treatment, were enrolled. They all received 2 consecutive intravitreal injections of 2.5 mg (0, 1 ml) of Etanercept (Enbrel), with a two-week interval. In all patients visual acuity assessment, fundoscopy and fluorescein angiography were performed prior to the first injection, weekly for the first month, as well as 2 and 3 months following the first injection. No adverse reactions or adverse events were noticed in any patient.

Analysis of the data indicates a trend for improvement of visual acuity, a slight worsening of hard exudates and fluorescein leakage, while hemorrhages remained stable, 3 months after initiation of therapy. However, no statistical significance has been reached.

This small pilot study did not reveal any improvement in the clinical course of patients with refractory diabetic macular edema after the intravitreal injection of etanercept. Further research is warranted in order to obtain conclusive results concerning the role of anti-TNF therapy in diabetic macular edema.

PMID: 17564925 [PubMed - in process]