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Age-Related Macular Degeneration clinical trials

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NCT ID: NCT02521142 Recruiting - Clinical trials for Age Related Macular Degeneration

Non-invasive Optical Angiography in Age-related Macular Degeneration

Start date: November 2015
Phase:
Study type: Observational

Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout Europe and the US. Among these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible for the most severe visual loss. There is now convincing evidence that vascular endothelial growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels, responsible for the development of the neovascular form of AMD. Today, the gold standard for vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the recent years tremendous enhancements in the field of optical coherence tomography have been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.

NCT ID: NCT02372916 Recruiting - Clinical trials for Age-related Macular Degeneration

Geographic Atrophy and Intravitreal Ranibizumab Injections

Start date: November 2014
Phase: N/A
Study type: Observational

Given the aging population who will be affected by wet AMD and lack of effective GA treatment, it is crucial to assess the safety profile of repeated ranibizumab injections in AMD patients with GA, particularly the possible risk of GA development and enlargement. This potential adverse effect has significant implication in the discussions with patients regarding the risks and benefits of AMD treatment and injection frequency. While monthly injections provide slight improvement of visual acuity at 2 years (Martin et al., 2012), the risk of GA enlargement may offset this benefit in visual acuity. Previous studies assessed the association between intravitreal ranibizumab injections and de novo GA development in injection-naïve eyes (Martin et al, 2012, Querques et al., 2012., Grunwald et al., 2014), rather than GA enlargement in patients with preexisting GA. To the best of the investigators knowledge, there has been no prospective study assessing the association between intravitreal ranibizumab injections and rate of GA progression in patients with pre-existing GA. There is also no prospective study comparing the morphological features of GA between patients who are receiving intravitreal injections and those who are not, nor the concordance of GA enlargement rate between the 2 eyes among patients receiving and not receiving treatment.

NCT ID: NCT02345317 Recruiting - Clinical trials for Age-related Macular Degeneration

Reticular Pseudodrusen Progression Study

Start date: December 2014
Phase: N/A
Study type: Observational

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrial countries. Reticular pseudodrusen (RPD) have been recognized as an additional phenotypic characteristic frequently observed in patients with AMD. Several studies have proven that the prevalence of RPD is associated with AMD as well as a high risk of disease progression to geographic atrophy, the late form of dry AMD. The pathogenesis of RPD is yet still incompletely understood. Retrospective studies have demonstrated that the RPD affected retinal area increases over time. Potential factors influencing progression of RPD have not been intensely studied and potentially predictive markers are yet unknown. The primary objective of this study is to characterize RPD progression in more detail and to identify predictive markers of RPD progression and development of AMD late stages.

NCT ID: NCT02296567 Recruiting - Clinical trials for Age Related Macular Degeneration

Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients

Start date: December 2014
Phase: Phase 2/Phase 3
Study type: Interventional

To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.

NCT ID: NCT02248324 Recruiting - Clinical trials for Age-related Macular Degeneration

Association of Previously Verified Gene Polymorphisms With AMD in Turkish Population

AMD-SNP
Start date: November 2012
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether common genetic polymorphisms that have been verified to be related to age-related macular degeneration (AMD) in some populations are also associated with AMD in Turkish population

NCT ID: NCT02173873 Recruiting - Clinical trials for Age Related Macular Degeneration

Ziv-aflibercept in Eyes With Retinal Diseases and Poor Vision-phase I

ZIV
Start date: June 2014
Phase: Phase 1
Study type: Interventional

Aflibercept is FDA approved and the same molecule is available as hyperosmolar for oncology (cost 800 USD for 4ml) and isoosmolar for Ophthalmology (cost 1,770 USD for 0.05ml injection). The 4ml bottle can be fractionated to be used in 40 patients hence the 0.05 ml injection would cost 20 USD for patients. Animal studies showed the injection is safe, knowing that the rabbit vitreous volume is 3-4 times smaller than the human eye. Our pilot study is to ascertain if the approved molecule for oncology when injected in the eye is safe as it is diluted into 5ml vitreous (100 times dilution). If this is so then we can save the patient 100 times for the most efficient antiVEGF that is used for maculopathy in various diseases (AMD, DME, CRVO, etc..)

NCT ID: NCT02102880 Recruiting - Clinical trials for Age-Related Macular Degeneration

The Role of Complement Factor H Polymorphism in the Regulation of Choroidal Vascular Tone in Young Healthy Subjects

Start date: March 2015
Phase: N/A
Study type: Interventional

Age related macular degeneration (AMD) is a multifactorial disease with a strong genetic component. Given that it is known that impaired regulation of choroidal vascular tone is present in patients with AMD, the current study seeks to investigate whether genetic polymorphisms in risk alleles for AMD are associated with altered choroidal blood flow regulation in healthy subjects. For this purpose a total of 220 healthy volunteers will be included. Choroidal blood flow regulation will be evaluated by measuring choroidal blood flow during isometric exercise. In addition, flicker induced vasodilatation will be studied and retinal vessel calibers will assessed, as well as retinal thickness and macular pigment optical density.

NCT ID: NCT02016508 Recruiting - Clinical trials for Age Related Macular Degeneration

Safety Study of Use of Autologous Bone Marrow Derived Stem Cell in Treatment of Age Related Macular Degeneration

Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral intravitreally transplantation of adult bone marrow stem cells in subjects with geographic atrophy secondary to age-related macular degeneration.

NCT ID: NCT01991730 Recruiting - Clinical trials for Age Related Macular Degeneration

Observational Study to Evaluate and Compare the Rate and Extent of Inflammation After a Single Injection of Ranibizumab vs. a Single Intravitreal Injection of Aflibercept in Treatment Naive and Treatment Experienced Patients

Start date: October 2013
Phase: N/A
Study type: Observational

This open-label, Phase IV prospective, observational study will evaluate patients, who have been diagnosed with Neovascular Age-Related Macular Degeneration and have previously received either a standard intravitreal injection of ranibizumab or aflibercept, in order to get and compare information regarding post-injection inflammatory (irritation in the eye)2-3 days post-injection. Additionally, patients will be evaluated for visual acuity and pain 2-3 days post-injection. THIS IS AN OBSERVATION STUDY AND NOT AN INTERVENTIONAL STUDY AS TO ENTER THIS STUDY SUBJECTS WILL HAVE HAD TO RECEIVED EITHER RANIBIZUMAB 0.5 MG OR AFIBERCEPT 2MG PRIOR TO ENTERING THE STUDY AND SIGNING CONSENT. THIS STUDY IS TO OBSERVE THE SUBJECT POST-INJECTION RECEIVED BEFORE ENTERING THIS STUDY.

NCT ID: NCT01879501 Recruiting - Glaucoma Clinical Trials

Living Successfully With Chronic Eye Diseases

ADAPT-LAH
Start date: January 2013
Phase: N/A
Study type: Interventional

The need for low vision services (LVS) will increase exponentially over the coming years due to the anticipated and exponential growth in the ageing population in Singapore and a rise in chronic non-communicable eye diseases. Finding the best evidenced-based management for chronic eye diseases contributing to low vision (LV) is therefore crucial. Improving patient responsibility is the key to managing LV effectively.1 This means achieving optimum self management (SM).2 However, there are currently no LV SM programs in Singapore and none has been evaluated using a randomized controlled trial (RCT) design, the gold standard methods to evaluate health interventions. The aims of this study are to assess the effectiveness of the 'Living Successfully with Low Vision (LSLV)' program in improving quality of life (QoL) in 160 elderly people with LV attending the Singapore National Eye Centre (SNEC) LV clinic. Of these, 80 will be randomly allocated to receive the LSLV 4-week SM program while the remaining 80 will receive the usual care. Comparisons will be made to determine the efficacy of the LSLV program. QoL, self-efficacy, emotional well being, and vision-specific distress will be assessed 2 weeks after training, and at six months and 12 months post intervention. This study will be the first evidenced-based RCT investigating the effectiveness of a novel vision-specific self-management strategy to improve QoL. It will also adopt a longitudinal design where the effectiveness of these interventions will be evaluated at 12 months-the first follow-up assessment of that duration at both national and international levels. Furthermore this will be the first study to characterize and profile the patients where the effect of the program did not demonstrate an improvement in both primary and secondary outcomes six months after its completion. The future clinical implications of this study include the potential to implement a successful model of LV rehabilitation in other tertiary centres around the country.