Inherited Retinal Degenerative Disease Registry
Eye Diseases HereditaryRetinal Disease26 moreThe My Retina Tracker® Registry is sponsored by the Foundation Fighting Blindness and is for people affected by one of the rare inherited retinal degenerative diseases studied by the Foundation. It is a patient-initiated registry accessible via a secure on-line portal at www.MyRetinaTracker.org. Affected individuals who register are guided to create a profile that captures their perspective on their retinal disease and its progress; family history; genetic testing results; preventive measures; general health and interest in participation in research studies. The participants may also choose to ask their clinician to add clinical measurements and results at each clinical visit. Participants are urged to update the information regularly to create longitudinal records of their disease, from their own perspective, and their clinical progress. The overall goals of the Registry are: to better understand the diversity within the inherited retinal degenerative diseases; to understand the prevalence of the different diseases and gene variants; to assist in the establishment of genotype-phenotype relationships; to help understand the natural history of the diseases; to help accelerate research and development of clinical trials for treatments; and to provide a tool to investigators that can assist with recruitment for research studies and clinical trials.
A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given...
Neovascular (Wet) Age-related Macular DegenerationResearchers are looking for a better way to treat people who have neovascular (wet) age-related macular degeneration (nAMD or wet AMD). In people with wet AMD, the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in the area of sharpest vision in the eye, called macula. Fluid buildup due to leakage from these vessels can damage the macula, leading to vision problems such as blurring or a blind spot in the central (straight ahead) vision needed for reading or face recognition or car driving. Wet AMD is common in people aged 50 and older. The study treatment intravitreal aflibercept (also called BAY865321) is injected into the eye. It works by blocking the VEGF protein and thus reduces blood vessel growth. It has already been approved for patients with wet AMD to be given as intravitreal injection monthly at start and then every 8 weeks or longer. Repeated injections of aflibercept prevent worsening of vision but place a burden on the patient. Doctors try to increase the time between injections (treatment interval) in routine clinical practice based on individual patient needs. This is called treat and extend (T&E). Treatment intervals are stepwise extended or shortened depending on how the treatment works. This is checked with optical coherence tomography (OCT), an imaging technique used to observe relevant changes in the eye. The main purpose of this study is to learn how well aflibercept works if treatment intervals are extended faster (timepoint of extension is the same for both treatments arms), compared to standard T&E regimen in people with wet AMD in a preselected patient population with no fluid after treatment initiation. To answer this, researchers will assess changes in vision called best corrected visual acuity (BCVA) between study start and after 36 weeks. Changes will then be compared between participants whose treatment intervals were extended early and those on standard T&E regimen. All participants will receive 2 mg aflibercept as intravitreal injection for up to 52 weeks in intervals of every 4 to 16 weeks. Each participant will be in the study for up to 56 weeks. During this time 4 visits to the study site are set for all participants. The other visits are set individually. A final phone call is planned 3 days after treatment at the end of study. During the study, the doctors and their study team will: check patients' eye health using various eye examination techniques (slit lamp microscopy, OCT, and ophthalmoscopy) that may necessitate eye drops to widen the pupil) measure patients' eye vision (BCVA) do physical examinations check vital signs ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, participants in the fast extension arm will be provided with a home monitoring OCT device.
Beovu Experience UZ Leuven
Age-Related Macular DegenerationReporting early real-world clinical data of consecutive patients on the use of Beovu® (brolucizumab) intravitreal injections in patients with neovascular age-related macular degeneration.
Mechanisms of Retinal Revascularization and Clinical Indicators of Neovascular AMD Relapse
Wet Macular DegenerationAge-related macular degeneration (AMD) is a chronic and progressive eye disease and is one of the leading causes of vision impairment globally. AMD is referred to as either the dry or the wet type, where the wet type (also called neovascular-AMD or nAMD) is a later stage of the disease with neovascularization and retinal edema being the main attributes. This will usually cause subacute distortion or loss of central vision in patients. Since 2004, a successful treatment alternative for nAMD has been ocular injections with anti-VEGF (anti-Vascular Endothelial Growth Factor), causing the neovascularization and edema to regress and vision to improve. However, injections have to be repeated, usually requiring 8 injections or more during the first year of treatment. This can cause both a risk for serious adverse effects and is a significant financial drain on health care resources. Patients undergoing treatment are at risk for retinal edema recurrence. The time interval tolerated between injections is individual, and the accepted treatment strategy of today is to gradually, in a stepwise manner, increase the interval between injections. For some patients this extension is well tolerated, but for many patients relapse of proliferations and retinal edema will recur. With state-of-the-art technology OCT-A (optical coherence tomography-angiography) in combination with the clinically, well established examination method of OCT (optical coherence tomography), the project group will study the phenotypic vessel and tissue changes that occur in between injections. Furthermore, the investigators will measure cytokines, chemokines and growth factors in blood samples and the tear film during different treatment stages to see if any single factor is prognostic for poorer response to treatment or relapse. In the short term, the project group hope that the knowledge gained from this project could lead to a better understanding of the mechanisms behind nAMD neovascular relapse and to apply this to routine screening in the clinics. In the longer term, the project group hope that elucidating the physical mechanisms and molecular changes could enable new targeted therapies to be developed. Aim 1: To characterize the phenotype of vessels in relapsing nAMD patients and compare to those without relapse using OCT-A imaging Aim 2: To investigate retinal edema and choroidal thickness in correlation with neovascular changes of relapsing nAMD Aim 3: To measure cytokines, chemokines and growth factors in the tear film before and during treatment with anti-VEGF for nAMD With our main hypothesis being: Relapse of nAMD in patients occurs principally through reconfiguration and vasodilatation of persistent non-regressed vessels following anti-VEGF treatment, while fully regressed vessels remain dormant
A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants...
Macular DegenerationAge-Related1 moreThe purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).
Efficacy and Safety of Lucentis® Use in Patients With Diabetic Macular Edema Evaluating a Spaced...
Macular EdemaMacular Degeneration1 moreThe study was designed to assess the efficacy and safety of Lucentis® (ranibizumab 0.5 mg) in diabetic patients presenting with reduced visual acuity due to diabetic macular edema and evaluating spacing out of follow-up after initial intensive treatment phase.
Efficacy and Safety Study of MC-1101 1% TID in the Treatment of Nonexudative Age-Related Macular...
Nonexudative Age Related Macular DegenerationThis is a Phase II/III vehicle controlled, double masked, single center study. A single eye of 60 individuals with mild to moderate nonexudative Age-Related Macular Degeneration (AMD) will be randomly assigned to receive either topical 1% MC-1101 or a vehicle control over 2 years. The study design will assess the efficacy, safety, and tolerability of MC-1101 for these patients. An analysis of the primary and secondary endpoints will be conducted when all subjects have completed 12, 18 and 24 months.
A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy...
Geographic AtrophyThe purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT) injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size change from baseline at Month 12.
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to...
Age-Related MaculopathyThe purpose of this study is to determine the efficacy, safety and tolerability of multiple doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration.
Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal...
Macular EdemaCystoid Macular Edema3 moreTo evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema after plaque radiotherapy of uveal melanoma.