Steroids diabetic macular edema

Vitreo-Retinal Surgery 
Vitrectomy is now a routinely performed surgery for several retinal disorders,. Recently we are performing these surgeries with much finer and more precise instrumentation. This is known as Micro-Incision Vitreous Surgery (MIVS). It has resulted more precise, technically advanced and safe surgery with better outcomes for the patient along with a faster recovery. Micro-Incision Vitreous Surgery remains the mainstay for surgical treatment of various disorders of the Vitreo-retina specially in use for Diabetic Retinopathy, Retinal Detachment , vitreous haemorrhage ,Macular Holes and ERM’s , endophthalmitis etc .

Vein occlusions can be treated with the use of intraocular injections of special medications such as corticosteroids or Avastin (an antibody that inhibits a chemical called vascular endothelial growth factor). In addition, laser treatment as well as a possible surgery may be indicated in some cases. These disease processes start relatively rapidly over the course of a few weeks or months, but may persist and heal over the course of 24-48 months. When the vein occlusions become so severe that they actually start interfering with the blood flow into the eye, these vein occlusions become ischemic (loss of blood flow to the retina), resulting in severe vision loss and much greater rates of complications such as neovascular glaucoma, a kind of glaucoma that can result in blindness very rapidly. Fortunately, with modern treatment, even these very late stages of disease can be treated to prevent loss of the eye and limit the amount of vision loss. Visual prognosis for these conditions is variable and very guarded. Your doctor will discuss with you the treatment options available for the specific vein occlusion seen in your eye.

On November 18, 2011, the FDA approved aflibercept ophthalmic solution (Eylea, Regeneron Pharmaceuticals Inc.) for the treatment of neovascular (wet) ARMD.  The FDA's approval of Eylea was based on positive results from the 2 phase III VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) trials.  Both found the drug non-inferior to ranibizumab, which is currently the most potent FDA-approved treatment option for wet ARMD.  The most commonly reported adverse events in patients receiving aflibercept included eye pain, conjunctival hemorrhage, vitreous floaters, cataract, and an increase in eye pressure.  Aflibercept should not be used in those who have an active eye infection or active ocular inflammation.  It has not been studied in pregnant women, so the treatment should be used only in pregnant women if the potential benefits of the treatment outweigh any potential risks.  Age-related macular degeneration does not occur in children and aflibercept has not been studied in children.  The recommended dose is 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

In addition to data from the 2 phase III clinical trials, data from phase I/II studies were also included in the FDA review.  In an open-label, 2-center, uncontrolled, randomized, phase I clinical trial, Rosenfeld and colleagues (2006) examined if multiple intravitreal doses of up to 2 mg of ranibizumab can be tolerated and are biologically active when injected using a dose-escalating strategy in eyes of patients with neovascular AMD.  A total of 32 patients with primary or recurrent sub-foveal choroidal neovascularization secondary to AMD were enrolled.  Baseline best-corrected VA in the study eye was from 20/40 to 20/640 (Snellen equivalent).  Treatment regimens consisted of 5, 7, or 9 intravitreal injections of ranibizumab at 2- or 4-week intervals for 16 weeks, with escalating doses ranging from to mg.  Patients were evaluated through day 140, 4 weeks after their last injection.  Safety was assessed based on ocular and non-ocular adverse events, changes in VA, changes in intraocular pressure (IOP), slit-lamp ocular examination, changes in lesion characteristics based on fluorescein angiography and color fundus photography, and the presence of anti-ranibizumab antibodies.  A total of 29 patients received an injection at baseline, and 27 patients completed the study through day 140.  Results were similar across the 3 treatment groups.  All patients experienced ocular adverse events, most of which were mild.  The most common ocular adverse events were iridocyclitis (83 %), and injection-site reactions (72 %).  Inflammation did not increase with repeated injections, despite the increasing ranibizumab doses.  Transient mild IOP elevations were common after ranibizumab injection.  No serum anti-ranibizumab antibodies were detected.  In general, median and mean VAs in the study eyes improved by day 140 in all 3 groups.  Only 3 of the 27 patients lost significant vision.  There was no significant lesion growth, and a decrease in area of leakage from choroidal neovascularization was detected through day 140.  The authors concluded that multiple intravitreal injections of ranibizumab at escalating doses ranging from to mg were well-tolerated and biologically active in eyes with neovascular AMD through 20 weeks.  Mild transient ocular inflammation was the most common post-injection adverse event.

Steroids diabetic macular edema

steroids diabetic macular edema

In addition to data from the 2 phase III clinical trials, data from phase I/II studies were also included in the FDA review.  In an open-label, 2-center, uncontrolled, randomized, phase I clinical trial, Rosenfeld and colleagues (2006) examined if multiple intravitreal doses of up to 2 mg of ranibizumab can be tolerated and are biologically active when injected using a dose-escalating strategy in eyes of patients with neovascular AMD.  A total of 32 patients with primary or recurrent sub-foveal choroidal neovascularization secondary to AMD were enrolled.  Baseline best-corrected VA in the study eye was from 20/40 to 20/640 (Snellen equivalent).  Treatment regimens consisted of 5, 7, or 9 intravitreal injections of ranibizumab at 2- or 4-week intervals for 16 weeks, with escalating doses ranging from to mg.  Patients were evaluated through day 140, 4 weeks after their last injection.  Safety was assessed based on ocular and non-ocular adverse events, changes in VA, changes in intraocular pressure (IOP), slit-lamp ocular examination, changes in lesion characteristics based on fluorescein angiography and color fundus photography, and the presence of anti-ranibizumab antibodies.  A total of 29 patients received an injection at baseline, and 27 patients completed the study through day 140.  Results were similar across the 3 treatment groups.  All patients experienced ocular adverse events, most of which were mild.  The most common ocular adverse events were iridocyclitis (83 %), and injection-site reactions (72 %).  Inflammation did not increase with repeated injections, despite the increasing ranibizumab doses.  Transient mild IOP elevations were common after ranibizumab injection.  No serum anti-ranibizumab antibodies were detected.  In general, median and mean VAs in the study eyes improved by day 140 in all 3 groups.  Only 3 of the 27 patients lost significant vision.  There was no significant lesion growth, and a decrease in area of leakage from choroidal neovascularization was detected through day 140.  The authors concluded that multiple intravitreal injections of ranibizumab at escalating doses ranging from to mg were well-tolerated and biologically active in eyes with neovascular AMD through 20 weeks.  Mild transient ocular inflammation was the most common post-injection adverse event.

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