[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Association for Innovation and Biomedical Research on Light and Image\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":146},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,63,93,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100619111","home-monitoring-in-eamd-treatment-100619111",false,"NCT07340372","Home Monitoring in eAMD Treatment","HOME","Inclusion Criteria:\n\n* Adults (≥ 55 years old) with exudative AMD in the study eye.\n* Treatment-naïve patients or patients who have started treatment with IVT anti-VEGF (aflibercept 2 mg, aflibercept 8 mg, faricimab, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) up to 48 weeks before inclusion.\n* BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 85 to 34 (approximate Snellen equivalent of 20\u002F20 to 20\u002F200) in the study eye with decreased vision determined to be primarily the result of eAMD.\n* Willing and able to comply with clinic visits and study-related procedures.\n* Provide informed consent signed by study participant or legally acceptable representative.\n* Own a working smartphone or tablet compatible with the OKKO Health application.\n* Be able to operate the application after training according to OKKO Health indications of use: be alert and mentally competent, has competent dexterity and has normal or corrected hearing to normal audio level.\n\nExclusion Criteria:\n\n* Evidence of macular edema due to any cause other than eAMD in either eye.\n* Other ocular disease in the study eye that could prevent an accurate evaluation of treatment efficacy like, diabetic macular edema, posterior uveitis, corneal opacity, vein occlusion, macular dystrophy.\n* IVT anti-VEGF or steroid implants (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium, triamcinolone, dexamethasone, fluocinolone) for more than 1 year before inclusion.\n* Treatment with ocriplasmin (JETREA®) in the study eye at any time.","ALL","55 Years",{"count":19,"type":20},80,"ESTIMATED","OBSERVATIONAL","The goal of this observational clinical study is to collect more information about the efficacy of Aflibercept 8 mg injections in people with eAMD. The main questions it aims to answer are:\n\n* To reassure patients and doctors with longer intervals using home monitoring app;\n* To assess patient reported outcomes (PROMs) and Value-based Healthcare.\n\nParticipants already taking Aflibercept 8 mg as part of their regular medical care for eAMD will undergo regular ophthalmological examination and use a home monitoring app, in a one year and a two-year treatment period.",[24],"Exudative Age-Related Macular Degeneration",[26,24,27,28,29],"Aflibercept 8 mg","Patient reported outcomes","Value-based Healthcare","Home monitoring app","NOT_YET_RECRUITING","2026-05-05",{"date":33,"type":34},"2026-05-06","ACTUAL",{"date":36,"type":20},"2026-05",{"date":38,"type":20},"2027-12",{"name":40,"class":41},"Association for Innovation and Biomedical Research on Light and Image","OTHER",8,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100598691","retinal-ganglion-cell-neuroprotection-under-prostaglandin-analogues-100598691","NCT07074782","Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues","Retinal Ganglion Cell Neuroprotection Under Prostaglandin Analogues: NEUROPA - a Retrospective Cohort Study","NEUROPA","Inclusion Criteria:\n\n* Age 18+ years\n* Established glaucoma diagnosis (primary open-angle glaucoma, normal tension Glaucoma, pseudoexfoliation glaucoma, pigmentary dispersion glaucoma) in either eye\n* Visual field mean deviation (MD; location-weighted mean difference from average age-corrected visual field sensitivity) of 2 visual fields differing by no more than 3 dB, for a mean deviation of better than -6.0 dB, or by no more than 4 dB, for a mean deviation worse than -6.0 dB, as measured using Humphrey perimetry (or equivalent Haag-Streit \u002F Octopus; in at least one eye; analogous to The United Kingdom Glaucoma Treatment Study)\n* Treatment with either prostaglandin analogues only or another topically applied IOP-lowering compound only for at least 3 years\n* Documented follow-up period of at least 3 years\n* At least 6 patient visits documented over the follow-up period with readings of IOP, visual field, OCT\n* No additional glaucoma intervention apart from laser trabeculoplasty and\u002For cataract surgery during the observational period\n\nExclusion Criteria:\n\n* Follow-up period \\\u003C 3 years\n* Number of patient visits \\\u003C6 visits\n* Number of OCT, visual field readings during the observation period \\\u003C 6\n* Low compliance\u002Ftherapy interruption\n* Beginning of combination therapy of prostaglandin analogues and other IOP lowering eye drops during the observation period\n* In case of glaucoma diagnosis in both eyes: different topical IOP-lowering treatment regimes (e.g. prostaglandin analogues in one eye and beta-adrenergic blocking agents in the fellow eye)\n* Additional glaucoma intervention during the observational period other than laser trabeculoplasty and\u002For cataract surgery","18 Years",{"count":53,"type":20},1500,"The goal of this observational study is to evaluate whether prostaglandin analogue eye drops have a direct neuroprotective effect on retinal ganglion cells - beyond their intraocular pressure (IOP)-lowering effect - in adult patients with glaucoma or ocular hypertension. The study includes individuals diagnosed with glaucoma (any sex\u002Fgender, adult age groups) undergoing standard clinical treatment. The main questions it aims to answer are:\n\n* Do prostaglandin analogues provide a neuroprotective effect on retinal ganglion cells that is independent of their IOP-lowering properties?\n* Should prostaglandin analogues be promoted\u002Ffavoured over other IOP-lowering compounds for long-term glaucoma management?\n\nResearchers will compare an interventional group, which consist of 750 eyes treated with prostaglandin analogues (e.g., latanoprost, travoprost, tafluprost, bimatoprost, unoprostone), with a control group, which consist of 750 eyes treated with non-prostaglandin IOP-lowering compounds (e.g., timolol, dorzolamide, brimonidine, netarsudil) to see if treatment with prostaglandin analogues is associated with better retinal ganglion cell survival over a period of 3 years (36 months).\n\nData will be collected from individuals who had at least 36 months of documented follow-up, with clinical data available at approximately 3, 6, 12, 24, and 36 months. Eligible individuals must have been treated with either prostaglandin analogues or other intraocular pressure (IOP)-lowering agents as part of routine clinical care. The data to be obtained from medical records will include at least:\n\n* Intraocular pressure readings\n* Visual field testing\n* OCT measures\n* Visual acuity\n* Adverse events\n* Treatment adherence\u002Fcompliance\n* Additional glaucoma interventions",[56],"Glaucoma",{"date":33,"type":34},{"date":36,"type":20},{"date":60,"type":20},"2026-06",{"name":40,"class":41},10,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":75,"conditions":76,"keywords":81,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100628198","longitudinal-observational-study-of-diabetic-retinopathy-progression-in-type-2-diabetes-patients-100628198","NCT07458516","Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients","IMaging Pre-PrOlifeRative sTAge of Diabetic retiNopaThy to Guarantee Timely Treatment - IMPORTANT","IMPORTANT","Inclusion Criteria:\n\n* Type 2 diabetes mellitus (T2D) according to 1985 World Health Organization (WHO) criteria.\n* Age between 35 and 80 years.\n* Best-corrected visual acuity (BCVA) ≥ 69 letters (20\u002F40).\n* Refraction with a spherical equivalent less than 5 diopters.\n* Non-proliferative diabetic retinopathy (NPDR; DRSS levels 43, 47, 53) or mild proliferative diabetic retinopathy (PDR; DRSS level 61: Neovascularization Elsewhere (NVE) \\\u003C ½ disc area in ≥ 1 quadrant, no Neovascularization of the Disc (NVD), no vitreous or sub-hyaloid hemorrhage), in which panretinal photocoagulation (PRP) and\u002For intravitreal anti-VEGF treatment can safely be deferred for at least 6 months, based on consensus between patient and investigator - using ETDRS criteria, 7-field equivalent area on ultra-widefield fundus imaging.\n* Ability to understand and sign the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Central subfield thickness (CST) \\> 400 μm (fluid allowed if CST ≤ 400 μm and foveal contour is normal, as determined by the Central Reading Centre, and treatment is not immediately required).\n* Any sign of retinal fibrovascular proliferation.\n* Uncontrolled glaucoma (intraocular pressure \\> 25 mmHg regardless of concomitant IOP-lowering medications) or neovascular glaucoma.\n* Any sign of iris neovascularization, vitreous, or pre-retinal hemorrhage.\n* Other retinal vascular diseases (ocular ischemic syndrome, retinal arterial or venous occlusion, exudative age-related macular degeneration, etc.).\n* Previous panretinal photocoagulation (PRP) or intravitreal injection treatment.\n* Any eye surgery within 6 months prior to the inclusion visit.\n* Significant media opacities including severe cataract, corneal scarring or edema, or vitreous hemorrhage that precludes fundus evaluation.\n* Pupil dilation \\\u003C 5 mm.","35 Years","80 Years",{"count":74,"type":20},100,"The purpose of this clinical study is to explore imaging, functional and systemic biomarkers of diabetic retinopathy (DR) progression, in Type 2 Diabetes (T2D) patients with moderate to severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) using state of the art methodologies, commonly applied in clinical practice, over a period of two years. This study will provide longitudinal data to better understand retinal changes in moderate to severe diabetic retinopathy and early proliferative diabetic retinopathy and help guide timely interventions to prevent vision loss.",[77,78,79,80],"Diabetic Retinopathy","Diabetes Mellitus, Type 2","Diabetic Complication","Retinal Disease",[82],"Disease biomarkers","RECRUITING","2026-03-09",{"date":86,"type":34},"2026-03-11",{"date":88,"type":34},"2025-11-24",{"date":90,"type":20},"2028-06",{"name":40,"class":41},1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":71,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":92},"100625036","analysis-of-dr-progression-to-identify-risks-and-need-for-treatment-100625036","NCT07417410","Analysis of DR Progression to Identify Risks and Need for Treatment","ALERT","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes according to the 1985 WHO criteria.\n* Age between 35 and 90 years.\n* Retrospective visit or referenced patients. For the retrospective visit, a documented follow-up of 1-5 years is required, with at least one clinical visit. For the referenced patients, it is required that they have either diabetic retinopathy at the baseline visit, the presence of at least one cardiovascular risk factor at the baseline visit, or cardiovascular complications at the baseline visit.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Previous laser photocoagulation or intravitreal injections (consider if corticosteroids were administered).\n* Presence of clinically significant macular edema (CSME) with vision loss or requiring immediate treatment.\n* Proliferative diabetic retinopathy.\n* Any ocular surgery within the previous 3 months.\n* Renal Replacement Therapy (Hemodialysis, Peritoneal Dialysis).\n* Severe systemic illness, subject to investigator's judgment.","90 Years",{"count":102,"type":20},1000,"The goal of this observational study is to understand whether vascular and structural changes in the eyes caused by diabetes can help predict which people are more likely to experience worsening diabetic retinopathy (a diabetes-related eye disease) and how these eye changes are related to cardiovascular complications.\n\nThe study will include about 1,000 people with type 2 diabetes, aged 35 to 90 years, and will take place over twelve months. It may also include a retrospective component, where existing medical and imaging data collected from previous visits (within the last 1 to 5 years) will be analyzed.\n\nThe main questions it aims to answer are:\n\n* Can eye vessel and tissue changes, observed through modern imaging techniques and clinical data, help better describe and predict which cases of diabetic retinopathy will become more severe?\n* Can these same eye changes help predict the presence and risk of cardiovascular problems-such as heart disease or stroke-in people living with type 2 diabetes?",[77],"2026-02-27",{"date":107,"type":34},"2026-03-02",{"date":109,"type":34},"2025-11-03",{"date":111,"type":20},"2027-11",{"name":40,"class":41},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":100,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100570599","phase-4-study-to-investigate-the-efficacy-safety-and-durability-of-faricimab-in-caucasian-patients-with-polypoidal-choroidal-vasculopathy-mondego-100570599","NCT06709339","Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)","A Phase IV, Multicentre, Open-label, Single-arm Study to Investigate the Efficacy, Safety and Durability of Faricimab (RO6867461) in Caucasian Patients With Polypoidal Choroidal Vasculopathy","MONDEGO","General Inclusion Criteria:\n\nPotential participants are eligible to be included in the study only if all of the following criteria apply:\n\n* Signed ICF\n* Age ≥ 50 years at the time of signing the ICF\n* Caucasian\n* Participants who are able to comply with the study protocol, in the investigator's judgment\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:\n\nFemale participants must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year, during the treatment period and for at least 3 months after the final dose of faricimab.\n\nA female participant is considered to be of childbearing potential if she is post-menarche, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n\nExamples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated concerning the duration of the clinical trial and the preferred and usual lifestyle of the individual.\n\nPeriodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.\n\nIf required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local ICF.\n\nOcular Inclusion Criteria for study eye:\n\n* Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis\n* Confirmed diagnosis, by the Reading Centre, of naïve symptomatic macular PCV defined by the following:\n\n  * Active macular polypoidal lesions shown by ICGA AND\n  * Presence of exudative or haemorrhagic features involving the macula as identified by the investigator using multimodal images.\n* BCVA scores of 78-24 ETDRS letters, inclusive (20\u002F32 to 20\u002F320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters \\[see the BCVA Standard Operational Procedures (SOP) for additional details\\] on study Day 1.\n\nGeneral Exclusion Criteria\n\nPotential participants are excluded from the study if any of the following criteria apply:\n\n* Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1\n* Any major illness or major surgical procedure within 1 month before screening\n* Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 (Grade Group of 1) and a stable prostate-specific antigen for ≥ 12 months\n* Continuous use of any medications and treatments indicated below:\n\n  * Systemic anti-VEGF therapy\n  * Systemic drugs known to cause macular oedema (fingolimod, tamoxifen)\n  * Other experimental therapies (except those comprising vitamins and minerals) and therapies that claim to have an effect on macular pathology (e.g., kallidinogenase)\n* Systemic treatment for suspected or active systemic infection on study Day 1\n* Ongoing use of prophylactic antibiotic therapy may be acceptable after discussion with the Medical Monitor.\n* Uncontrolled blood pressure, defined as systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg while the participant is at rest on study Day 1\n* History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1\n* History of other diseases, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the IMP or that might affect the interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator\n* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anaesthetic and antimicrobial preparations used by a participant during the study\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab\n\nOcular Exclusion Criteria\n\nPotential participants are excluded from the study if any of the following criteria apply to both eyes:\n\n* History of idiopathic or autoimmune-associated uveitis in either eye\n* Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1\n\nParticipants who meet any of the following ocular criteria for the study eye will be excluded from study entry:\n\n* Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular haemorrhage, IRF, or SRF\n* Retinal pigment epithelial tear involving the macula on study Day 1\n* Diagnosis with or suspected of having narrow-angle glaucoma who have not undergone iridotomy. The inclusion of these patients will be conditional upon prior referral to the relevant specialist for appropriate treatment to enable participation in the study.\n* On FFA\u002Fcolour fundus photograph (CFP):\n\n  * Subretinal haemorrhage of \\> 4 macular photocoagulation study disc area and\u002For that involves the fovea\n  * Fibrosis or atrophy of \\> 50% of the total lesion area and\u002For that involves the fovea\n  * Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study\n  * Current vitreous haemorrhage on study Day 1\n  * Advanced\u002For uncontrolled glaucoma\n  * Spherical equivalent of refractive error demonstrating more than 8 dioptres of myopia\n* Any prior or concomitant treatment for PCV or other retinal diseases, including, but not restricted to, IVT treatment (e.g., faricimab, anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin PDT, diode laser, transpupillary thermotherapy, or ocular surgical intervention\n* Any cataract surgery or treatment for complications of cataract surgery with steroids or yttrium-aluminum-garnet (YAG) laser capsulotomy within 3 months prior to study Day 1\n* Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy)\n* Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases\n* Continuous use of any medications and treatments indicated below:\n\n  * IVT anti-VEGF agents (other than study-assigned faricimab)\n  * IVT, periocular (subtenon), steroid implants (i.e., Ozurdex®, Illuvien®), or chronic topical ocular corticosteroids (defined as continuous usage for 100 days or longer)\n  * Concurrent use of any macular photocoagulation or PDT with verteporfin Participants who have a non-functioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits will be excluded from study entry.","50 Years",{"count":123,"type":20},120,"INTERVENTIONAL",[126],"PHASE4","The goal of this clinical trial is to assess the efficacy, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV). The main question it aims to answer is:\n\nTo evaluate the efficacy of intravitreal (IVT) injections of faricimab 6 milligrams (mg) on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular PCV.\n\nParticipants will undergo ophthalmic examination, safety assessment and treatment with faricimab according to a patient specific treat and extend regimen.",[129],"Polypoidal Choroidal Vasculopathy",[131,132,133,134,135,136],"Faricimab","Caucasian patients","PCV","Durability","Safety","Efficacy","2026-02-05",{"date":139,"type":34},"2026-02-06",{"date":141,"type":34},"2025-08-06",{"date":143,"type":20},"2028-08",{"name":40,"class":41},31,""]