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Macular Degeneration Clinical Trials

Do you have a close relative who has been diagnosed with Macular Degeneration? With no definitive Macular Degeneration Cure currently available, the quest for a cure has driven multiple Macular Degeneration Clinical Trials and research.

Because Dry ARMD is the more common form of the Eye Disease, much effort has been channeled toward finding effective treatment for it, with the hope of arresting the disease process from converting to the rarer, visually debilitating Wet ARMD form.

Evidence to support treatment strategies for Dry ARMD comes from:

  • Studies, known as Histopathological, of tissue changes characteristic of ARMD.
  • Animal models
  • Studies, known as Epidemiological, which attempt to determine what factors are associated with ARMD (risk factors) and what factors may protect people or animals against ARMD (protective factors).
  • Nutritional studies
  • Genetic association studies
  • Macular Degeneration Clinical Trials
  • ARMD is a multi-factorial Eye Disease and thus is being attacked on many fronts as a result of the evidence provided by the different types of studies noted above.

    Current Macular Degeneration Clinical Trials and Research

    (1)Age-Related Eye Disease Study 2 (AREDS 2) is a follow-up study to AREDS, which showed that high levels of antioxidants and zinc significantly reduce the risk of advanced ARMD and its associated vision loss.

    The goals of AREDS 2 are to evaluate the effect of:

  • Two dietary macular xanthophylls, Lutein 10 mg/zeaxanthin 2 mg

    • Two omega-3 long-chain polyunsaturated fatty acids (LCPUFAs):• 350 mg Docosahexaenoic acid (DHA)• 650 mg Eicosapentaenoic acid (EPA)o Assess the effects of eliminating beta-carotene from the original AREDS formulation on the development of ARMD.o Evaluate the effects of reducing zinc the original AREDS formulation on the development and progression of ARMD.

    The inclusion criteria for the study were:• Patients with large drusen in both eyes or • Patients with large drusen in one eye and advanced ARMD in the other eye.• Men and women between the ages of 50 and 85 yearsAREDS 2 start date was in September 2006 and estimated study completion date is December 2012. AREDS 2 is active, but not recruiting.

    • ACU-4429 in Patients with Geographic Atrophy is a study with the purpose of evaluating the following aspects of the investigational drug ACU-4429 in Patients with Geographic Atrophy:o Safety, o Tolerability, o Pharmacokinetics (which has to do with how the drug is absorbed, distributed, metabolized and eliminated by the body),o Pharmacodynamics (which has to do with studying the side effects on the body)

    The inclusion criteria for the study is having a clinical diagnosis of Geographic Atrophy, as defined in the protocol.

    This drug suppresses rod photoreceptor function which in turn decreases the creation of toxic byproducts such as lipofuscin and A2E, which can accumulate in the Retinal Pigment Epithelium and lead to damage.

    The study is administering ACU-4429 as a pill in 2, 5, 10 or 20 mg tablets taken orally once daily for 90 days, as opposed as by injection like many other treatments. The control group is taking a placebo once daily too.The ACU-4429 in Patients with Geographic Atrophy study began in October 2009 with an estimated completion date of May 2011. This study is recruiting.

    • ARC 1905 in Patients with Geographic Atrophy is a study with the purpose of evaluating the safety and tolerability of ARC 1905 intravitreous injection in Patients with Geographic Atrophy.

    The inclusion criterion for the study is having Dry ARMD (drusen and/or Geographic Atrophy) in both eyes. This study began in October 2009 and has an estimated primary completion date of May 2011.

    • Brimonidine in Patients with Geographic Atrophy. Brimonidine can release various neurotrophins, including brain-derived neurotrophic factor (BDNF) and ciliary neurotrophic factor (CNTF). These neurotrophins have a potential to prevent cell death of photoreceptors and/or RPE. Neurotrophins are a family of proteins that promote the survival, development, and function of neurons.

    Stage 1 was a patient-masked, dose-escalation, safety evaluation of Brimonidine intravitreal implant. Patients received implant in one eye and no treatment in the other eye. Treated versus untreated eyes were then compared over time.

    The inclusion criteria for this study include:• Geographic Atrophy in both eyes due to Dry ARMD• Visual acuity between 20/40 to 20/320

    Stage 2 is currently active, but not recruiting. The study is using Brimonidine formulated in the Allergan Novadur™ delivery system. This drug delivery system is comprised of a solid biodegradable polymer based sustained drug release formulation for with an applicator for intravitreal injections.

    Image retrieved from: http://www.myvisiontest.com/newsarchive.php?id=1081The implant is available in two doses 200µg or 400µg for the study eye. The other eye receives no treatment. The two are then compared after every 6 months. Patients will be followed for up to 2 years.

    The Brimonidine in Patients with Geographic Atrophy study began in May 2008 with an estimated completion date of December 2011.

    • Weekly Vaccination with Copaxone in patients with Dry ARMD: The recruitment status of this study is unknown.

    • Eculizumab in Patients with Dry ARMD including Geographic Atrophy. The purpose of this study is to evaluate the safety and efficacy of Eculizumab in Patients with Dry ARMD as evaluated by the change in drusen volume and area of Geographic Atrophy.

    The study started on July 2009 with an estimated primary completion date of July 2011. This study is currently recruiting participants.

    • Geographic Atrophy Treatment Evaluation (GATE): The purpose of this study is to evaluate AL-8309B as a topical ocular treatment for Geographic Atrophy secondary to ARMD. It is randomized, multi-center, and placebo-controlled.

    The eye drop is given twice per day. In live model, the drug used in GATE provided dose-dependent protection of retinal function and structure as well as decreased accumulation of by-products of oxidative stress to levels not different from those observed in controls.

    o Eligibility criteria• Age ≥55 years• Well-demarcated area of Geographic Atrophy secondary to ARMD with specific size requirements• No evidence of CNV• 20/200 Snellen equivalent or better

    The study began April 2009 and has an estimated primary completion date of February 2012.

    • Intravitreal Injections of FCFD4514S in Patients with Geographic Atrophy: This Phase 1a study of this new human monoclonal antibody will consist of a single-dose, dose-escalation study of the safety and tolerability of an intravitreal (ITV) injection of FCFD4514S in Patients With Geographic Atrophy.

    The study started in September 2009 and is ongoing, but not currently recruiting.Inclusion criteriao 50-85 years oldo GA at least 0.75 disc areas in the absence of CNVo BCVA 20/125 to 20/400 inclusiveo GA resides completely within the color fundus photos

    • Iluvien® in Patients with Advanced ARMD including Geographic Atrophy: Iluvien® is a non-degradable Fluocinolone acetonide implant that has a therapeutic effect of 24-36 months but with much higher side-effects.

    Clinical Trials are underway to compare steroids against or in combination with Anti-VEGF (Avastin) therapy.

    One study is a randomized, double-masked, fellow-eye comparison of the safety and efficacy of 0.2 (low dose) and 0.5 (high dose) µg/day of Fluocinolone acetonide intravitreal insert to sham injection in subjects with bilateral Geographic Atrophy due to ARMD.

    This study began in December 2008 and has an estimated primary completion date of December 2011.

    • RN6G in Patients with Advanced ARMD including Geographic Atrophy: Pfizer has developed Intravenous RN6G, which is an antibody against amyloid beta.

    Amyloid beta is a protein that accumulates in the brains of individuals with Alzheimer’s disease and it is the main constituent of the harmful plaques that develop in animal models of Alzheimer’s disease.

    Similar to the plaques that develop in patients with Alzheimer’s disease are the drusen that develop in the retinas of patients with ARMD.Phase 1 Clinical Trials of the agent is completed and initial findings demonstrated Intravenous RN6G to be safe and well tolerated.

    Intravenous RN6G is currently in Phase 2 Clinical Trials which are currently recruiting. The purpose of the study is to determine the safety and tolerability of multiple doses of RN6G in Patients with Advanced ARMD including Geographic Atrophy.

    The study start date was August 2010 and its estimated completion date is May 2012.

    • Sirolimus in Patients with Geographic Atrophy: The purpose of this study is to determine if Sirolimus is safe to give to Patients with Geographic Atrophy and if it can help preserve vision in patients.

    Geographic Atrophy (GA) may at least partly be caused by inflammation. Sirolimus helps prevent inflammation and therefore may treat GA.

    Inclusion criteriao Visual acuity between 20/20 and 20/400 in each eyeo Older than 55 years of age or oldero Must have at least ½ disc area (approximately 1 mm) of GA compatible with ARMD present in each eye.o Must have at least one large drusen in each eye.

    The study start date was October 2008 and its estimated completion date is July 2011.

    Much research and effort is being channeled toward the treatment of ARMD and particularly, stopping the progression from Dry ARMD with Geographic Atrophy to Wet ARMD, which may help minimize vision loss. For other treatment alternatives, go to FDA Approved Macular Degeneration Treatments, Experimental Treatments for ARMD, Macular Degeneration Cure, and New treatment for Macular degeneration.


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