Active clinical trials for "Macular Degeneration"

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.

The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.

Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections. Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic. In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the American Society of Retina Specialists (the largest retina society in the world) asked about anesthetic methods for administering intravitreal injections, the following response was given by the 433 respondents: Topical anesthetic drop: 21.48% Topical viscous anesthetic: 23.33% Topical anesthetic & soaked cotton-tip or pledget: 29.79% Subconjunctival injection of anesthetic: 24.02% Other: 1.39% An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing optimal anesthetic prior to intravitreal injections. (Prenner 2011).

Age-related macular degeneration (AMD) is by far the most common disorder in the group of irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process and severely compromises the highly developed functions of the macula, such as perception of details, central fixation, color vision, and reading ability. AMD-related visual impairment is associated with a loss of autonomy and quality of life. Current therapeutic approaches target vascular endothelial growth factor (VEGF), which has been identified as a main cytokine in the pathogenesis of nAMD. Ranibizumab, the fab-fragment of an antibody targeting VEGF is approved for the treatment of nAMD applied intravitreally in monthly intervals until the disease activity is stopped. However, a significant proportion of patients with nAMD suffer from persistent or recurring disease with the need of continuous anti-VEGF therapy over months and years, often leading to irreversible changes in the photoreceptor layer and the pigment epithelium. Recent studies regarding the treatment of nAMD utilized different forms of therapies, combining photodynamic therapy with verteporfin (PDT) and ranibizumab, as well as therapeutic regimen containing steroids. Even though these studies did not provide evidence that combination therapies are superior to ranibizumab monotherapy, studies were only conducted with patients with previously untreated nAMD. Therefore, currently there is no alternative therapeutic approach for patients with recurrent or persistent form of nAMD after multiple treatments with ranibizumab monotherapy. The purpose of this study is to assess the treatment effect of reduced fluence PDT and intravitreal ranibizumab versus intravitreal dexamethasone and ranibizumab versus intravitreal ranibizumab monotherapy in patients with persistent or recurrent choroidal neovascularization (CNV) due to AMD. The investigators hypothesis is that these findings will offer new insights in the management of persistent or recurrent CNV secondary to AMD.

An epiretinal membrane is scar tissue on the retina that can cause blurring and distortion of vision and lead to swelling, or macular edema. Despite surgery to remove the scar tissue(membrane peeling), residual swelling of the retina may continue to interfere with vision. In this study the investigators will inject an implantable steroid device into the back, fluid-filled portion of the eye. Steroids have been found to decrease the swelling in the retina. Ozurdex™ is an implantable steroid. Once implanted, Ozurdex™ is slowly dissolved by the vitreous gel that fills the eye, releasing the steroid. The steroid drug delivery system in this study, known as Ozurdex™ has been FDA-approved by the US Food and Drug Administration (FDA) for decreasing swelling due to another condition in the eye. This study will help to find out whether or not this device Ozurdex™ is also effective for reducing the swelling of the retina in patients who have already had surgery to remove scar tissue on the retina.

The investigators assume that ranibizumab might be dangerous in patients with history of coronary artery disease or cerebrovascular events. The main objective of study is to reveal contraindications for ranibizumab prescription in patients with history of coronary artery disease and cerebrovascular events. Moreover, an association between management with ranibizumab and ATE rate in healthy above 50 years old persons is a concern of great interest as well.

The purpose of this first in man study is to examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.

The purpose of this study is to compare the effectiveness of intravitreal bevacizumab injection (IVBI) with respect to simple observation in patients with subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) presenting at baseline with best corrected visual acuity (BCVA) less than 20/200.

The current norm in clinical practice for the treatment of choroidal neovascular membranes (CNVM) secondary to Age-related Macular Degeneration(AMD) involves monthly injections of Ranibizumab until the disease is stabilized. At this point, most physicians tend to follow one of two treatment regimens. 'Treat -and-observe' entails regular follow-up of stable patients, with treatment thereafter only in the presence of disease recurrence. Alternatively, in a 'treat-and-extend' dosing strategy, intervals between treatments are extended as long as disease remains stable. Many clinicians, who employ a treat-and-extend dosing regimen, do not extend their treatment intervals beyond 3 months. However, it is possible that the subgroup of patients on every three months 'treat-and-extend' dosing may represent a uniquely, stable population that would perform particularly well on an observational regimen with regular follow-up. We hypothesize that there will be a low CNVM recurrence rate in wet AMD patients stable on every three months Ranibizumab dosing ('treat-and-extend'), who begin a treat-and-observe protocol.