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Current Eye Research Dec 2012To compare the efficacy of intravitreal (IV) triamcinolone acetonide (IVTA) versus subtenon (ST) triamcinolone acetonide (STTA) injection for the treatment of diabetic... (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
To compare the efficacy of intravitreal (IV) triamcinolone acetonide (IVTA) versus subtenon (ST) triamcinolone acetonide (STTA) injection for the treatment of diabetic macular edema (DME).
METHODS
Searches for randomized clinical trials published between 1 January 1950 and 15 March 2011 were conducted using PubMed, MEDLINE, EMBASE, and the Cochrane Library included in the present meta-analysis are five randomized controlled trials, each with a minimum follow-up of 3 mo. All included studies evaluated the efficacy of TA for the treatment of refractory DME, and compared IVTA with STTA by measuring visual acuity (VA), central macular thickness (CMT), and intraocular pressure (IOP).
RESULTS
One mo post-injection, treatment with IVTA had significantly improved VA (MD, -0.14 logMAR; 95% CI = -0.16 to -0.13) and reduced CMT (MD = -174.02 μm; 95% CI = -249.97 to -98.08) compared with STTA. At 3 mo post-injection, treatment with IVTA had significantly improved VA (MD = -0.07 logMAR; 95% CI = -0.09 to -0.05) and reduced CMT (MD = -119.46 μm; 95% CI = -176.55 to -62.36) compared with STTA. The benefits of either treatment were no longer significant at 6 mo, and patients had to be retreated. Compared with STTA, IVTA injections produced no difference in IOPs at 1 mo, higher IOPs at 3 mo, and lower IOP values at 6 months
CONCLUSIONS
Within 3 mo, IVTA is more effective than is STTA in improving VA and reducing CMT in patients with refractory DME. However, the benefits of either regimen were no longer evident at 6 mo.
Topics: Clinical Trials as Topic; Diabetic Retinopathy; Glucocorticoids; Humans; Intraocular Pressure; Intravitreal Injections; Macular Edema; Tenon Capsule; Treatment Outcome; Triamcinolone Acetonide; Visual Acuity; Vitreous Body
PubMed: 22793880
DOI: 10.3109/02713683.2012.705412 -
Retina (Philadelphia, Pa.) Jan 2011To review the current management and pharmacologic treatment of pseudophakic cystoid macular edema. (Comparative Study)
Comparative Study Review
PURPOSE
To review the current management and pharmacologic treatment of pseudophakic cystoid macular edema.
METHODS
Systematic review of currently accepted treatment modalities for pseudophakic cystoid macular edema. Main outcome measures include visual acuity and retinal thickness measurement by optical coherence tomography.
RESULTS
Optical coherence tomography is used to diagnose and monitor response to therapy. New topical nonsteroidal antiinflammatory drugs have been approved by the Food and Drug Administration for ophthalmic use, and some show promise in the treatment of pseudophakic cystoid macular edema. Other areas of clinical research include the use of anti-vascular endothelial growth factor agents and the addition of intravitreal routes of administration (e.g., corticosteroids, nonsteroidal antiinflammatory drugs, and anti-vascular endothelial growth factor agents). Surgical therapeutic options include Nd:YAG laser for anterior vitreolysis and pars plana vitrectomy for chronic refractory cases.
CONCLUSION
Surprisingly, few changes have occurred in recent years in the treatment of pseudophakic cystoid macular edema. Placebo-controlled, double-masked, randomized, clinical trials are largely lacking.
Topics: Administration, Topical; Adrenal Cortex Hormones; Anti-Inflammatory Agents, Non-Steroidal; Carbonic Anhydrase Inhibitors; Humans; Injections, Intraocular; Laser Therapy; Macular Edema; Ophthalmologic Surgical Procedures; Primary Prevention; Pseudophakia; Retina; Tomography, Optical Coherence; Vascular Endothelial Growth Factor A; Visual Acuity; Vitrectomy; Vitreous Body
PubMed: 21187730
DOI: 10.1097/IAE.0b013e3181fd9740 -
Canadian Journal of Ophthalmology.... Jun 2010As the off-label use of intravitreal bevacizumab continues for an increasing number of ocular conditions, a systematic review of the literature aimed at detecting... (Review)
Review
OBJECTIVE
As the off-label use of intravitreal bevacizumab continues for an increasing number of ocular conditions, a systematic review of the literature aimed at detecting temporally associated systemic adverse events was undertaken.
DESIGN
Systematic review of the literature and a health regulatory database.
PARTICIPANTS
A total of 22 different clinical studies representing 12,699 patients.
METHODS
A systematic review indexed by Ovid MEDLINE, EMBASE, ISI Web of Science, the Cochrane database (CENTRAL), and the Canadian Adverse Drug Reaction Information System Database was performed. All clinical studies with at least 100 eyes injected with bevacizumab and case reports documenting suspected events were included for review.
RESULTS
A total of 22 different clinical studies were reviewed, including an international internet survey, 6 retrospective studies assessing the safety of intravitreal bevacizumab, and 15 clinical trials. The most common adverse systemic event reported in these studies, representing 12,699 patients was an increase in blood pressure (0.46% of patients), followed by cerebrovascular accidents (0.21% of patients), and myocardial infarction (0.19% of patients). The 6 case reports documented suspected events not previously identified and only 1 systemic event from the Health Canada database was retrieved.
CONCLUSIONS
The systemic events temporally associated with intravitreal bevacizumab are mainly of cardiovascular and neurological origin and can be predicted from an exaggerated pharmacology, although a causal association cannot be established at this time. Health Canada's spontaneous drug reporting system is an underutilized resource and a more active surveillance system such as a patient registry may be better suited to establish the low rates of systemic adverse events following bevacizumab use in ophthalmology.
Topics: Adverse Drug Reaction Reporting Systems; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Bevacizumab; Canada; Databases, Factual; Humans; Injections; Vascular Endothelial Growth Factor A; Vitreous Body
PubMed: 20628421
DOI: 10.3129/i10-027 -
The Cochrane Database of Systematic... Jul 2010Proliferative vitreoretinopathy (PVR) is a significant cause of failure in retinal reattachment surgery. Various pharmacological agents have shown potential benefit in... (Review)
Review
BACKGROUND
Proliferative vitreoretinopathy (PVR) is a significant cause of failure in retinal reattachment surgery. Various pharmacological agents have shown potential benefit in reducing postoperative PVR risk.
OBJECTIVES
This review aimed to compare the use of intravitreal low molecular weight heparin (LMWH) alone or with 5-Fluorouracil (5-FU) versus placebo, as an adjunct in the prevention of PVR following retinal reattachment surgery.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2010, Issue 5), MEDLINE (January 1950 to May 2010), EMBASE (January 1980 to May 2010), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (http://clinicaltrials.gov). There were no language or date restrictions in the search for trials. The electronic databases were last searched on 24 May 2010.
SELECTION CRITERIA
We only included randomised controlled trials (RCTs) that compared intravitreal LMWH alone or with 5-FU, versus placebo for the prevention of postoperative PVR in patients undergoing primary vitrectomy for rhegmatogenous retinal detachment repair.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. The review authors contacted study authors for additional information.
MAIN RESULTS
We included two RCTs (with a total of 789 participants) comparing LMWH with 5-FU infusion and placebo. However, we did not perform a meta-analysis because of significant heterogeneity between these studies. One study found a significant beneficial effect of LMWH with 5-FU in reducing postoperative PVR compared to placebo (RR: 0.48, 95% confidence interval: 0.25 to 0.92), in 174 patients who were viewed at high-risk of developing postoperative PVR. The other study included 615 unselected cases of rhegmatogenous retinal detachment and could not show a difference between LMWH with 5-FU infusion and placebo in reducing PVR rates (RR:1.45, 95% confidence interval: 0.76 to 2.76).
AUTHORS' CONCLUSIONS
Results from this review indicate that there is inconsistent evidence from two studies on patients at different risk of PVR on the effect of LMWH and 5-FU used during vitrectomy to prevent PVR. Future research should be conducted on high risk patients only, until a benefit is confirmed at least in this patient subgroup.
Topics: Fluorouracil; Heparin, Low-Molecular-Weight; Humans; Injections, Intraocular; Postoperative Complications; Randomized Controlled Trials as Topic; Retinal Detachment; Vitreoretinopathy, Proliferative; Vitreous Body
PubMed: 20614445
DOI: 10.1002/14651858.CD006421.pub2 -
Current Opinion in Ophthalmology May 2010We conducted a systematic review to evaluate whether the existing evidence justifies the intravitreal use of bevacizumab in comparison to ranibizumab in age-related... (Comparative Study)
Comparative Study Review
PURPOSE OF REVIEW
We conducted a systematic review to evaluate whether the existing evidence justifies the intravitreal use of bevacizumab in comparison to ranibizumab in age-related macular degeneration.
RECENT FINDINGS
Compared with photodynamic therapy, bevacizumab shows a relative improvement in visual acuity that is of similar size as in the comparison of ranibizumab with photodynamic therapy (relative improvement from 30 to 35%). However, this finding is based on one randomized controlled trial including less than 50 patients treated with bevacizumab. Also, nothing is known about long-term (>12 months) improvements in visual acuity and optimal treatment intervals for bevacizumab.Regarding safety, the published literature indicates that ocular and systemic adverse effects are less frequent under bevacizumab than ranibizumab treatment. But the validity of this finding is strongly limited by inadequate reporting, an unsystematic evaluation of adverse effects and short follow-up times in studies evaluating bevacizumab.
SUMMARY
Given the lack of controlled data, the widespread off-label use of bevacizumab is not justified in clinical practice. On the other hand, a major challenge in the management of patients who require repeated antivascular endothelial growth factor injections is the high cost of ranibizumab. This dilemma underlines the need for head-to-head studies comparing both vascular endothelial growth factor antibodies, or, at least, well conducted randomized controlled trials evaluating intravitreal bevacizumab.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Bevacizumab; Humans; Injections; Macular Degeneration; Ranibizumab; Treatment Outcome; Vascular Endothelial Growth Factor A; Vitreous Body
PubMed: 20393293
DOI: 10.1097/ICU.0b013e3283386783 -
Acta Ophthalmologica Jun 2010This study aimed to evaluate the evidence for the effects of steroid injection in addition to macular laser grid (MLG) photocoagulation versus those of MLG... (Review)
Review
OBJECTIVES
This study aimed to evaluate the evidence for the effects of steroid injection in addition to macular laser grid (MLG) photocoagulation versus those of MLG photocoagulation alone on visual acuity (VA) in patients with diabetic macular oedema (DMO).
METHODS
An extensive literature search in Medline (PubMed), Experta Medica (EMBASE) and the Cochrane Library (CENTRAL) using synonyms for MLG photocoagulation, steroid injection and DMO found 181 articles. Of the articles that met selection criteria, three studies in which patients receiving MLG photocoagulation were randomized to additional pretreatment with steroids provided the best available evidence. In addition to VA, central foveal thickness (CFT) was measured at baseline and at 6 months in all three studies.
RESULTS
Two studies, with total populations of 73 and 42 eyes, respectively, reported no additional effect of steroid injection on VA. One study, with a total of 41 eyes, reported a beneficial effect of pretreatment with steroids on VA of -0.21 ETDRS logMAR units. All three studies reported larger reductions in CFT in eyes pretreated with steroids, the smallest of which was 64 microm.
CONCLUSIONS
Although there is a greater reduction in CFT in eyes pretreated with steroids, this does not consistently result in higher VA. The literature search does not provide sufficiently strong evidence to recommend steroid injection before MLG photocoagulation in DMO.
Topics: Combined Modality Therapy; Diabetic Retinopathy; Glucocorticoids; Humans; Injections; Laser Coagulation; Macular Edema; Triamcinolone Acetonide; Visual Acuity; Vitreous Body
PubMed: 20222888
DOI: 10.1111/j.1755-3768.2009.01657.x -
Ophthalmology May 2009To compare intravitreal triamcinolone acetonide (IVTA) injection versus no treatment or sub-Tenon triamcinolone acetonide (STTA) injection in improving visual acuity... (Comparative Study)
Comparative Study Review
OBJECTIVE
To compare intravitreal triamcinolone acetonide (IVTA) injection versus no treatment or sub-Tenon triamcinolone acetonide (STTA) injection in improving visual acuity (VA) of patients with refractory diabetic macular edema (DME; unresponsive to focal laser therapy).
CLINICAL RELEVANCE
Diabetic macular edema is the leading cause of visual loss in diabetic retinopathy. Laser therapy has been the standard of care for patients with persistent or progressive disease. More recently, it has been suggested that IVTA injection may improve VA. METHODS AND LITERATURE REVIEWED: The following databases were searched: Medline (1950-September Week 2 2008), The Cochrane Library (Issue 3, 2008), and the TRIP Database (up to September 1, 2008), using no language or other limits. Randomized controlled trials were included that consisted of patients with refractory DME, those comparing IVTA injection with no treatment or STTA injection, those reporting VA outcomes, and those having a minimum follow-up of 3 months.
RESULTS
In the 4 randomized clinical trials comparing IVTA injection with placebo or no treatment, IVTA injection demonstrated greater improvement in VA at 3 months, but the benefit was no longer significant at 6 months. Those who received IVTA injection had significantly higher IOP at 3 months and at 6 months. In the 2 randomized clinical trials comparing IVTA injection with STTA injection, IVTA injection demonstrated greater improvement in VA at 3 months, but not at 6 months. Intravitreal triamcinolone acetonide injection demonstrated no difference in IOP at 3 months or at 6 months.
CONCLUSIONS
Intravitreal triamcinolone acetonide injection is effective in improving VA in patients with refractory DME in the short-term, but the benefits do not seem to persist in the long-term.
FINANCIAL DISCLOSURE(S)
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
Topics: Aged; Databases, Factual; Diabetic Retinopathy; Female; Glucocorticoids; Humans; Injections; Intraocular Pressure; Macular Edema; Male; Middle Aged; Randomized Controlled Trials as Topic; Treatment Outcome; Triamcinolone Acetonide; Visual Acuity; Vitreous Body
PubMed: 19410949
DOI: 10.1016/j.ophtha.2009.02.002 -
Archivos de La Sociedad Espanola de... Oct 2008Systematic review on efficacy and safety of intravitreal bevacizumab (IVB) in the treatment of neovascular glaucoma (NVG). All original papers published in Medline... (Review)
Review
PURPOSE
Systematic review on efficacy and safety of intravitreal bevacizumab (IVB) in the treatment of neovascular glaucoma (NVG). All original papers published in Medline (prior to August 2008) were included.
METHODS
Search and selection of information on the internet and in Medline, validated by Kappa Index (K). Statistical and clinical study of the results in the selected articles on a one by one basis.
RESULTS
26 original papers analyzed the efficacy and safety of the procedure in case reports and short series of cases (127 eyes). The efficacy calculated in the sample was 68.7% and the recurrence rate was 18.6% in 4.2 months of follow-up. All studies were after 2006 and none of them was a clinical randomized controlled assay. Ophthalmic complications were under 0.78% and no systemic complications were found.
CONCLUSIONS
The use of bevacizumab demonstrates that intravitreal injections may be effective and useful to manipulate growth factors in the anterior chamber. IVB could serve as a first line treatment for NVG. Clinical trials are needed to confirm these results before its use is authorized.
Topics: Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Bevacizumab; Glaucoma, Neovascular; Humans; Injections; Vitreous Body
PubMed: 18855277
DOI: 10.4321/s0365-66912008001000004 -
The Cochrane Database of Systematic... Jan 2008Macular edema is secondary to leakage from diseased retinal capillaries and is an important cause of poor central visual acuity in patients with diabetic retinopathy. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Macular edema is secondary to leakage from diseased retinal capillaries and is an important cause of poor central visual acuity in patients with diabetic retinopathy.
OBJECTIVES
This review evaluated the effectiveness and safety of intraocular steroids in treating diabetic macular edema (DME).
SEARCH STRATEGY
We searched CENTRAL, MEDLINE, EMBASE in June 2007, reference lists, Science Citation Index and conference proceedings.
SELECTION CRITERIA
We included randomized clinical trials (RCTs) evaluating any form of intravitreal steroids for treating DME.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed eligibility, methodological quality and extracted data. We performed meta-analyses when appropriate.
MAIN RESULTS
Seven studies, involving 632 DME eyes were included. Four examined the effectiveness of intravitreal triamcinolone acetate injection (IVTA), three examined intravitreal steroids implantation (fluocinolone acetonide implant (FAI) or dexamethasone drug delivery system (DDS)). Two trials were at low risk of bias, one was at median risk of bias, two were at high risk of bias and the remaining two were at unclear risk of bias. The preponderance of data suggest a beneficial effect from IVTA. Comparing IVTA with controls, the mean difference in visual acuity was -0.15 LogMAR (95% CI -0.21 to -0.09) at 3 months (based on three trials), -0.23 LogMAR (95% CI -0.33 to -0.13) at 6 months (two trials), -0.29 LogMAR (95% CI -0.47 to -0.11) at 9 months (one trial), and -0.11 LogMAR (95% CI -0.20 to -0.03) at 24 months (one trial), all in favor of IVTA. The relative risk (RR) for one or more lines improvement in visual acuity was 2.85 (95% CI 1.59 to 5.10) at 3 months (two trials), 1.25 (95% CI 0.66 to 2.38) at 6 months (one trial), and 2.17 (95% CI 1.15 to 4.11) at 24 months (one trial), all in favor of IVTA. We did not find evidence for three or more lines improvement in visual acuity. The mean difference in retinal thickness was -131.97 um (95% CI -169.08 to -94.86) at 3 months (two trials), -135.00 um (95% CI -194.50 to -75.50) at 6 months (one trial), -133.00 um (95% CI -199.86 to -66.14) at 9 months (one trial), and -59.00 um (95% CI -103.50 to -14.50) at 24 months (one trial), all in favor of IVTA. The RR for at least one grade macular edema resolution was 5.15 (95% CI 2.23 to 11.88) at 3 months in favor of IVTA (one trial). Two trials reported improved clinical outcome when FAI was compared to standard of care. Beneficial effect was also observed in one dexamethasone DDS trial. Increased intraocular pressure and cataract formation were side effects requiring monitoring and management.
AUTHORS' CONCLUSIONS
RCTs included in this review suggest that steroids placed inside the eye by either intravitreal injection or surgical implantation may improve visual outcomes in eyes with persistent or refractory DME. Since the studies in our report focused on chronic or refractory DME, the question arises whether intravitreal steroids therapy could be of value in other stages of DME, especially the earlier stages either as standalone therapy or in combination with other therapies, such as laser photocoagulation.
Topics: Anti-Inflammatory Agents; Dexamethasone; Diabetic Retinopathy; Drug Implants; Fluocinolone Acetonide; Glucocorticoids; Humans; Injections; Macular Edema; Randomized Controlled Trials as Topic; Steroids; Triamcinolone; Visual Acuity; Vitreous Body
PubMed: 18254088
DOI: 10.1002/14651858.CD005656.pub2 -
BMJ Clinical Evidence Nov 2007Diabetic retinopathy is the most common cause of blindness in the UK, with older people and those with worse diabetic control, hypertension, and hyperlipidaemia being... (Review)
Review
INTRODUCTION
Diabetic retinopathy is the most common cause of blindness in the UK, with older people and those with worse diabetic control, hypertension, and hyperlipidaemia being most at risk. Diabetic retinopathy can cause microaneurysms, haemorrhages, exudates, changes to blood vessels, and retinal thickening.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments in people with diabetic retinopathy? What are the effects of treatments for vitreous haemorrhage? We searched: Medline, Embase, The Cochrane Library and other important databases up to November March 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 29 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: peripheral retinal laser photocoagulation, focal and grid laser photocoagulation for maculopathy, corticosteroids for macular oedema, and vitrectomy for vitreous haemorrhage.
Topics: Diabetic Retinopathy; Humans; Laser Coagulation; Macular Edema; Visual Acuity; Vitreous Body
PubMed: 19450351
DOI: No ID Found