Laser and Medical Treatment of Diabetic Macular Edema
Macular DegenerationThis study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes. In macular edema, blood vessels in the retina, a thin layer of tissue that lines the back of the eye become leaky and the retina swells. The macula, the center part of the retina that is responsible for fine vision may also swell, causing vision loss. Traditional laser treatment (argon blue or green or yellow) for macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision. Studies with a different type of laser (diode) may be less damaging. The results of this study on side effects of the treatments will be used to design a larger study of effectiveness. This study will also examine whether celecoxib (Celebrex® (Registered Trademark)), an anti-arthritis drug that reduces inflammation and swelling, can reduce inflammation and swelling of the retina. Patients with elevated cholesterol levels will be invited to participate in a cholesterol reduction part of the study to compare normal-pace cholesterol reduction with accelerated reduction. Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema that requires laser treatment may be eligible for this study. Candidates will be screened with the following tests and procedures: Medical history: to review past medical conditions and treatments. Physical examination: to measure vital signs (pulse, blood pressure, temperature, breathing rate) and examine the head and neck, heart, lungs, abdomen, arms and legs. Eye examination: to assess visual acuity (eye chart test) and examine pupils, lens, retina, and eye movements. The pupils will be dilated with drops for this examination. Blood tests: to measure cholesterol, blood clotting time, hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney function. Eye photography: to help evaluate the status of the retina and changes that may occur in the future. Special photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye. From 2 to 20 pictures may be taken, depending on the eye condition. Fluorescein angiography: to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. Participants will be randomly assigned to take celecoxib or placebo (an inactive, look-alike pill). Participants who have elevated cholesterol levels may return for a brief visit after 1 month. All patients will return for follow-up visits at 3, 6, and 12 months. Patients who require laser treatment will be randomly assigned to one of the two laser treatments. For these procedures, eye drops are put in the eye to numb the surface and a contact lens is placed on the eye during the laser beam application. Several visits may be required for additional laser treatments. The maximum number of treatments depends on how well the treatment is working. Patients who respond well to the study medication may receive no laser treatments. After the first year, patients will be followed every 6 months until either the patient returns for a 3-year visit, the last enrolled patient returns for the 1-year visit, or the patient requests to leave the study. During the follow-up visits, patients' response to treatment will be evaluated with repeat tests of several of the screening exams.
Submacular Surgery Trials (SST)
Macular DegenerationHistoplasmosisTo determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often than observation. To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS, or idiopathic causes changes the patient's perception of health- and vision-related "quality of life," as measured by telephone interview using the Medical Outcomes Survey Short Form-36 (MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye Institute Visual Function Questionnaire (NEI VFQ-25). To determine whether randomized trials of surgery are warranted for patients with subfoveal CNV associated with age-related macular degeneration not suitable for laser treatment.
Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular...
Wet Age-related Macular DegenerationThis study will evaluate the therapeutic effects and safety of 800 mg ALK4290 administered daily over a 6-week dosing period in newly diagnosed patients with wet age-related macular degeneration (wAMD).
Progression of Early Atrophic Lesions
Age-Related Macular DegenerationEarly atrophic age-related macular degeneration (AMD) represents an important time window in the course of so far untreatable atrophic AMD, as patients typically experience only some degree of visual dysfunction, while being at significant risk for marked further loss of vision. To allow the precise evaluation of upcoming therapeutic interventions, a better understanding of the manifestation and variable disease progression is needed. This project aims to investigate refined tools to detect and monitor early atrophic AMD more accurately, including the impact on visual dysfunction and quality of life.
Visual Rehabilitation Through Acoustic Biofeedback With Retimax Vision Trainer in Patients With...
Macular Degeneration AdvancedMacular Degeneration5 moreAt present there are no real therapies able to improve visual performance in patients with age-related macular degeneration, atrophic type. The aim of the study is to verify whether with rehabilitation sessions with Retimax Vision Trainer it is possible to teach the maculopathic patient to exploit the extrafoveal areas of the retina, not affected by atrophy, resorting to an eccentric vision that compensates for the foveal one, thus obtaining a improvement of visual outcomes (far and near vision capacity, sensitivity to contrast to reading, reading speed, fixation capacity and overall quality of life of the visually impaired patient suffering from atrophic senile maculopathy (AMD)). To do this, the study design was conceived as a non-randomized prospective comparative and involves the formation of two groups of patients: a group A of 15 patients who will be rehabilitated with Retimax and a group B of 15 patients who will not be rehabilitated, but only re-evaluated at the same distance of time that will elapse for group A. Eligible patients are affected by atrophic AMD with unstable fixation and better vision in the eye between 1/10 and 4/10 in the absence of other serious eye diseases. As there is currently no real therapy capable of improving visual performance, the demonstration of the positive effect of the visual rehabilitation program with Retimax in patients suffering from atrophic macular degeneration may encourage a wider use of this method. The patient could benefit from a non-invasive, repeatable and cost-effective procedure.
A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular...
Neovascular Age Related Macular DegenerationNeovascular age-related macular degeneration (nAMD) is characterized by the presence of choroidal neovascularization (CNV). Choroidal neovascularization consists of abnormal blood vessels originating from the choroid and can lead to hemorrhage, fluid exudation, and fibrosis, resulting in photoreceptor damage and vision loss. The safety and efficacy of brolucizumab has been demonstrated in 2 randomized, multicenter, double-masked, active controlled Phase 3 studies in nAMD patients (RTH258-C001 and RTH258-C002). Anatomical changes were evaluated in these studies using spectral domain optical coherence tomography (SD-OCT), which relied on indirect parameters for the diagnosis of active CNV. The OCT-angiography (OCT A) that directly visualize retinal circulation and image CNV and vascular diseases of the retina was not included in previous brolcuizumab studies. This single-arm, open-label, multicenter study is being performed to evaluate the efficacy and safety of brolucizumab 6 mg in patients with nAMD. OCT-A will be used in this study to assess the morphological response of patients to brolucizumab in terms of percentage change in CNV lesion area in the short term (i.e. at Week 12) and in the long term (i.e. at Week 48), as well as changes in other OCT-A features up to Week 48. Approximately 210 adult patients will be screened and included in centers in France. The maximum study duration for 1 patient is 48 weeks. Patients will be required to attend 6 mandatory study visits: Screening/Baseline Visit (Day 1), Week 4, Week 8, Week 12, Week 16 and Week 48 visits. The timing of the interim visits between Week 16 and Week 48 will depend on the patient's injection regimen, i.e. every 8 weeks or every 12 weeks according to disease activity assessed by the investigator.
ReCLAIM-2 Study to Evaluate Safety,Efficacy & Pharmacokinetics of Elamipretide in Subjects With...
Age-related Macular DegenerationA randomized, double-masked, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of elamipretide in subjects with Age-Related Macular Degeneration with non-central Geographic Atrophy.
Connection Between Periodontitis and Exudative Age-related Macular Degeneration
PeriodontitisAqueous flare is increased in different kind of inflammations of eye. This is caused by disruption of blood-aqueous-barrier. The investigators assume that low grade systemic inflammation, such as periodontitis, increase aqueous flare and possibly activates exudative age-related macular degeneration.
Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular AMD
Neovascular Age-related Macular DegenerationTo evaluate the safety, efficacy and pharmacokinetics of repeated intravitreal administration of ALT-L9 2 mg/50uL compared with Eylea in patients with neovascular Age-related macular degeneration.
Time Course of Activity Signs at SD-OCT High Frequency Intravitreal Ranibizumab Treatment in CNV...
Choroidal NeovascularizationAge Related Macular DegenerationThe purpose of the study is to detect persisting or early new activity of choroidal neovascularization (CNV) due to age related macular degeneration (AMD) during the first 12 months following the first ranibizumab dose at baseline as assessed by weekly high resolution optical coherence tomography (OCT). Detection of persisting or new signs of CNV activity at OCT triggers further ranibizumab treatments considering that any ranibizumab injections can maximally be applied as often as 2-weekly.