[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-proliferative-diabetic-retinopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-proliferative-diabetic-retinopathy":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100611015","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-otx-tki-axitinib-implant-in-participants-with-non-proliferative-diabetic-retinopathy-100611015",false,"NCT07235085","A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy","A Phase 3, Multicenter, Double-Masked, Randomized, 3-Arm Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTXTKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy","HELIOS-3","Inclusion Criteria:\n\n1. Male or female who is at least 18 years of age at the time of signing the informed consent form (ICF)\n2. History of or newly diagnosed with type 1 or 2 diabetes mellitus and have moderately severe to severe NPDR (DRSS levels 47 or 53), confirmed by the Central Reading Center (CRC) based on the images obtained at the Screening visit\n3. BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of ≥ 69 letters (approximate Snellen equivalent of 20\u002F40 or better) in the study eye\n4. Willing and able to comply with clinic visits and study-related procedures\n5. Provide signed informed consent\n\nExclusion Criteria:\n\n1. Presence of center-involved diabetic macular edema (CI-DME) defined per protocol via optical coherence tomography (SD-OCT) in the study eye, obtained at the Screening visit\n2. Evidence of a rhegmatogenous retinal detachment or visually significant\u002Fsevere epiretinal membrane, vitreomacular traction syndrome, macular hole, tear of the retinal pigment epithelium in the macula, or other macular pathology in the study eye deemed visually significant by the Investigator\n3. In the study eye, any panretinal photocoagulation (PRP) treatment prior to baseline, or received focal or grid laser photocoagulation within 1000 microns of the central subfield of the macula within 6 months prior to baseline\n4. IVT anti-VEGF treatment in the study eye within 6 months or port delivery system (PDS) with ranibizumab in the study eye at any time prior to baseline (Day 1)\n5. (There are additional exclusion criteria)","ALL","18 Years",{"count":20,"type":21},930,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this trial is to study the safety and effectiveness of OTX-TKI (axitinib intravitreal hydrogel) for the treatment of Non-Proliferative Diabetic Retinopathy.\n\nOTX-TKI is an intravitreal hydrogel embedded with axitinib. When the OTX-TKI hydrogel is administered into the vitreous cavity of the eye, the hydrogel begins to slowly break down, which allows the axitinib to be slowly released over time.\n\nThis clinical trial is comparing OTX-TKI to a \"sham\" injection procedure. The sham injection is a mock injection procedure, but nothing will actually be inserted in the eye as there is no needle on the sham injector. Only one eye (\"study eye\") will be treated with study treatment.",[27],"Non-Proliferative Diabetic Retinopathy",[27],"RECRUITING","2026-03-12",{"date":32,"type":33},"2026-03-16","ACTUAL",{"date":35,"type":33},"2025-11-17",{"date":37,"type":21},"2027-03",{"name":39,"class":40},"Ocular Therapeutix, Inc.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100612926","phase-2-safety-and-proof-of-concept-study-of-anxv-annexin-a5-in-patients-with-diabetic-retinopathy-or-retinal-vein-occlusion-100612926","NCT07259928","Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion","Open-label, Safety, Tolerability and Proof of Concept Study to Evaluate the Use of ANXV (Recombinant Human Annexin A5 Protein) in the Treatment of Patients With Either Diabetic Retinopathy or Recent Onset Retinal Vein Occlusion","NEXUS","Inclusion Criteria:\n\nTo be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Must have given written informed consent (signed and dated), and any authorizations required by local law and be able to comply with all study requirements\n2. Male or female, ≥18 years of age at the time of informed consent\n3. Females should have no childbearing potential according to Clinical Trial Facilitation Group (CTFG) definition.\n4. Clear ocular media and adequate pupillary dilation in the Study Eye to permit high quality retinal imaging\n5. Willing to refrain from unusually strenuous exercise\u002Factivity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 72 hours prior to study visits\n\n   Additionally, NPDR participants must meet the following criteria to be eligible:\n6. Diagnosed with moderately severe or severe non-proliferative Diabetic Retinopathy defined as having a DRSS score of 47 and 53 respectively, and no CI-DMO\n7. Found to have an ETDRS BCVA score in the study eye (SE) of ≥69 ETDRS (equivalent to Snellen 6\u002F12 or 20\u002F40)\n\n   Additionally, RVO participants must meet the following criteria to be eligible:\n8. Diagnosed with Retinal Vein Occlusion with onset of symptoms within 28 days prior to first administration of ANXV\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\nGeneral:\n\n1. Unwillingness or inability to attend all study visits and\u002For perform all procedures\u002Ftests\u002Fexaminations, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator\n2. Any major medical or surgical procedure or trauma within 4 weeks prior to the day of trial intervention Treatment 1 (ANXV administration), or planned major surgery within the duration of the study through Day 120\n3. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study\n4. Prior exposure to a recombinant Annexin A5 protein\n5. History of severe allergy\u002Fhypersensitivity or ongoing allergy\u002Fhypersensitivity, as judged by the Investigator, or history of hypersensitivity to biologics (for example systemically administered recombinant proteins\u002Fpeptides; a similar drug class to ANXV)\n6. Uncontrolled hypertension (systolic \\> 180 mmHg or diastolic \\> 110 mmHg)\n7. Current use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib) or corticosteroids\n8. Diagnosed untreated systemic metastasis malignancy\n9. A current systemic infection or inflammation that may require antiviral or antimicrobial therapy that will not be completed prior to Screening Visit, or that in the opinion of the Investigator and with concurrence of the Medical Monitor may either put the participant at risk or may influence the results of the study, or the participant's ability to participate in the study\n10. Treatment with another investigational drug, biological agent, or device within 3 months of Screening Visit, or 5 half-lives of investigational agent, whichever is longer or planned participation in an interventional trial from signing Informed Consent Form (ICF) through Day 120\n11. History of thromboembolic events or deep venous thrombosis within 3 months of Screening Visit\n12. Current use of anticoagulant medication (any medications that might have effect on coagulation, haemostasis, and platelets); low dose aspirin allowed prior to informed consent but must be stopped at the time of consent; may begin again 1 day post Treatment 5 infusion\n13. Current daily use of benzodiazepines\n14. Clinically significant abnormal coagulation parameters at baseline\n15. History of autoimmune disease with anticipated presence of persistent Annexin A5 antibodies, e.g., antiphospholipid syndrome, systemic lupus erythematosus, rheumatoid arthritis, Behcet disease or systemic sclerosis\n16. Inherited blood disorder (e.g. sickle cell disease, thalassemia)\n17. History of unstable coronary artery disease or cerebrovascular accident within the last 3 months\n18. Current known kidney disease or evidence of kidney disease and eGFR below 60 mL\u002Fmin\u002F1.73m2 at baseline\n19. Current drug or alcohol abuse as per the opinion of the Investigator, or current excessive nicotine intake (e.g. ≥ 20 cigarettes\u002Fday, or equivalent, as per the opinion of the Investigator)\n20. Known history of or positive test for chronic infection that affect the immune system (e.g. hepatitis C (HCV), chronic hepatitis B (HBV) and HIV)\n21. Class III obesity (Body Mass Index ≥ 40kg\u002Fm2), at the time of informed consent\n22. Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens, or optic nerve (e.g., deferoxamine, chloroquine\u002Fhydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol)\n23. Known hypersensitivity or allergy to fluorescein (e.g., bronchospasm, rash, etc.) or to any component of the study products or a contraindication to dilation of the pupil or fixed pupils; mild allergies without angio-oedema or treatment need may be acceptable if deemed not to be of clinical significance (including but not limited to allergy to animals or mild seasonal hay fever)\n\n    Either or both eyes:\n24. A severe (≥0.9 log, Grade 3+ or worse) Relative Afferent Pupillary Defect (RAPD)\n25. An IOP greater than 24 mmHg that is not controlled with medication or surgery at the time of the Screening Visit\n26. Recent (6 months) history of, or presence of uveitis, presence of intraocular inflammation (history of blepharitis is not exclusionary), current ocular infection\n27. Evidence of neovascularization\n28. ETDRS BCVA score in the Fellow eye of ≤54 (equivalent to Snellen 6\u002F24 or 20\u002F80)\n29. Ocular disorders\u002Fadditional eye disease, which in the opinion of the Investigator may confound interpretation of study results, compromise protocol assessments or are likely to require intervention during the study, including, but not limited to, atrophy of the retinal pigment epithelium, sub-retinal fibrosis, organized hard exudate plaque, retinal detachment, macular hole, vitreomacular traction, macular epiretinal membrane, clinically significant cataract, vitreous opacities or haemorrhage, glaucoma with documented visual field loss, ischemic optic neuropathy, retinitis pigmentosa or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, toxoplasmosis, or pathologic myopia)\n30. Receipt within the past 6 months or ongoing intravitreal injection of anti-VEGF treatment in either eye\n\n    Study Eye only:\n31. Evidence of deep intraretinal haemorrhage involving the centre 1mm of the macula\n32. Laser photocoagulation in the study eye within the preceding 6 months prior to the Screening Visit, or likely to receive during the study period\n33. Intraocular surgery (including refractive surgery, cataract surgery), or intravitreal (IVT) injection within the preceding 6 months prior to the Screening Visit, or cataract surgery within the preceding 3 months prior to the Screening Visit, or planned intraocular surgery or procedure during the study\n34. Recent (6 months) history, or current evidence of ocular herpetic diseases (including herpes simplex virus, varicella zoster or cytomegalovirus)\n\n    NPDR participants will not be eligible if they meet any of the following criteria (only NPDR participants):\n35. CI-DMO in either eye which, in the opinion of the Investigator, qualifies for anti-VEGF or laser treatment",{"count":51,"type":21},12,[53],"PHASE2","The goal of this clinical trial is to learn about the safety of the investigational medicinal product ANXV. It will also learn about how ANXV works to treat non-proliferative diabetic retinopathy and retinal vein occlusion in adults. The main questions it aims to answer are:\n\n* Is ANXV safe to use?\n* Does ANXV improve vision or findings related to vision decrease caused by non-proliferative diabetic retinopathy or retinal vein occlusion?\n* Does ANXV lower the number of times participants need to use a rescue medication? Researchers will compare different dose levels of ANXV to see what dose would be be appropriate to test in larger studies.\n\nParticipants will:\n\nTake ANXV as a 30 minutes infusion (slow injection) for 5 days. Visit the clinic for checkups and tests at 11 visits during 4 months.",[27,56],"Retinal Vein Occlusion",[58,59,56,60,61,62],"Annexin A5","ANXV","Non-Profilerative Diabetic Retinopathy","RVO","NPDR","2025-11-28",{"date":65,"type":33},"2025-12-02",{"date":67,"type":33},"2025-11-07",{"date":69,"type":21},"2026-07",{"name":71,"class":40},"Annexin Pharmaceuticals AB",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100578897","phase-3-clinical-study-on-the-efficacy-and-safety-of-tntl-in-the-treatment-of-non-proliferative-diabetic-retinopathy-100578897","NCT06817265","Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy","Phase III Clinical Study on the Efficacy and Safety of TNTL in the Treatment of Non-proliferative Diabetic Retinopathy(With Syndrome of Yin Deficiency With Internal Heat and Blood Stasis Obstructing the Collaterals of the Eyes)","TNTL","Inclusion Criteria:\n\n* Age range of 18 to 75 years old (including boundary values);\n* Conform to the diagnosis of type 2 diabetes and diabetes retinopathy. diabetes retinopathy is classified as NPDR and mild and moderate patients;\n* Patients with the best corrected visual acuity (BCVA) of the target eye is ≥ 34 points (ETDRS visual acuity chart, visual acuity equivalent to a score of 20\u002F200, decimal 0.1);\n* Patients who meet the syndrome differentiation criteria of Yin deficiency, internal heat, and eye meridian stasis in traditional Chinese medicine;\n* During the screening period, glycated hemoglobin (HbA1c) should be ≤ 8.5%;\n* Agree to participate in this clinical study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with no light perception in one eye;\n* Patients with macular edema who require anti Vascular Endothelial Growth Factor(VEGF) treatment;\n* People with other eye diseases, such as retinal artery or vein occlusion, non diabetes retinopathy, retinal detachment, uveitis, glaucoma, corneal ulcer, cataract affecting fundus examination, optic neuropathy and high myopia with fundus changes;\n* Patients with acute complications of diabetes (such as diabetes ketoacidosis, hyperglycemia hyperosmolality syndrome, diabetes lactic acidosis, etc.) within one year before the screening period;\n* People with other eye related complications of diabetes, such as iris neovascularization, angle neovascularization, and retinal neovascularization;\n* acupuncture and moxibustion and other external treatment methods of traditional Chinese medicine were used to treat diabetes retinopathy within one week before enrollment;\n* Patients who have used drugs clearly stated in the instruction manual to treat diabetes retinopathy, such as calcium dobesilate, pancreatic kallidinogenase, Qiming Granules, Shuangdan Mingmu Capsules, Compound Danshen Dropping Pills, Tongluo Mingmu Capsules, etc. within 2 weeks before enrollment;\n* Patients who have undergone glaucoma, vitreous, retinal and other intraocular surgeries and procedures in the target eye within 3 months before enrollment;\n* Patients who have undergone cataract surgery in the target eye within 3 months prior to enrollment and have not yet stabilized according to the researcher's assessment;\n* Patients who have received intravitreal injections of anti VEGF antibodies and glucocorticoids in the target eye within 3 months prior to enrollment;\n* Patients who have undergone total retinal laser photocoagulation treatment in the target eye;\n* For those whose refractive media is turbid and difficult to evaluate fundus images in the target eye;\n* Uncontrolled or controlled blood pressure with systolic blood pressure ≥ 160mmHg and\u002For diastolic blood pressure ≥ 100mmHg;\n* When screening, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) should be ≥ 1.5 times the upper limit of normal value;\n* Patients with serious kidney disease (such as azotemia and uremia), diabetes foot, etc;\n* When screening, individuals with severe primary diseases such as respiratory, cardiovascular, cerebrovascular, endocrine, digestive, and hematopoietic systems, or those with severe mental illnesses should be included;\n* Suspected or confirmed history of alcohol or drug abuse;\n* Pregnant women, lactating women, or women of childbearing age who are preparing to conceive; Female subjects of childbearing age or male subjects (with partners of childbearing age) who do not agree to voluntarily take effective contraceptive measures within one month after the last dose during the screening period;\n* Individuals who are allergic to the drugs or their components used in this experiment;\n* Participants who have participated in other clinical trials within the past month;\n* The researchers believe that participants should not participate in the clinical trial.","75 Years",{"count":82,"type":21},360,[24],"The goal of this clinical trial is to learn if drug TNTL works to treat non-proliferative diabetic retinopathy in adults. It will also learn about the safety of drug TNTL. The main questions it aims to answer are:\n\n1. Does drug TNTL can improve visual acuity and reduce the degree of retinopathy?\n2. What medical problems do participants have when taking drug TNTL? Researchers will compare drug TNTL to a placebo (a look-alike substance that contains no drug) to see if drug TNTL works to treat non-proliferative diabetic retinopathy.\n\nParticipants will:\n\n1. Take drug TNTL or a placebo every day for 6 months\n2. Visit the clinic once every 4 weeks for checkups and tests\n3. Keep a diary of their symptoms and Change from baseline",[27],"2025-08-22",{"date":88,"type":33},"2025-08-24",{"date":90,"type":33},"2025-04-29",{"date":92,"type":21},"2026-12-31",{"name":94,"class":40},"Beletalent (Zhuhai) Pharmaceutical Co., Ltd",30,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100570936","remote-ischemic-conditioning-for-non-proliferative-diabetic-retinopathy-100570936","NCT06713720","Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy","Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy (RIC-NPDR)","RIC-NPDR","Inclusion Criteria:\n\n* Age between 40 and 80 years.\n* Diagnosed with Type 2 diabetes mellitus.\n* Diagnosed with mild to moderate non-proliferative diabetic retinopathy (NPDR) with a DR Severity Score (DRSS) grade of 20-47D.\n* Capable of performing daily activities independently.\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Presence of diabetic macular edema (macular thickness \\> 250 μm).\n* Significant eye diseases affecting evaluation, such as high myopia, severe cataract, corneal leucoma, glaucoma, retinal detachment, retinal vein occlusion, congenital eye diseases, ocular tumors, or severe infection.\n* History of ocular laser or intraocular surgery.\n* Poor imaging quality due to refractive media opacity.\n* Contraindication to fluorescein fundus angiography.\n* Unstable blood glucose (HbA1c ≥ 8.0%) despite oral antidiabetic drugs.\n* Severe diabetes complications within the past 6 months.\n* Severe, sustained hypertension (systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg).\n* Body mass index (BMI) ≥ 28 kg\u002Fm².\n* Hepatic or renal insufficiency: Alanine aminotransferase or aspartate aminotransferase \\> 2 times the upper limit of normal. Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m². Urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg.\n* Myocardial infarction within the past 6 months.\n* Neurological diseases such as Alzheimer's, Parkinson's, cerebrovascular disease, intracranial tumor, cerebrovascular malformation, or aneurysm.\n* Contraindications to RIC, including one-sided subclavian artery stenosis, upper limb injuries or vascular diseases, or limb deformities.\n* Severe systemic diseases, such as malignant tumors with a life expectancy of less than 24 months.\n* Known pregnancy or breastfeeding.\n* Participation in other experimental clinical studies.\n* Any other conditions deemed unsuitable by the investigator.","40 Years","80 Years",{"count":107,"type":21},68,[109],"NA","The goal of this clinical trial is to evaluate whether remote ischemic conditioning (RIC) is a safe and effective treatment for non-proliferative diabetic retinopathy (NPDR) in adults aged 40-80 years with type 2 diabetes. The study aims to address the limitations of current treatments for NPDR by using RIC, a technique involving repeated cycles of ischemia and hypoxia stimulation to activate protective mechanisms against retinal damage.\n\nThe main questions it aims to answer are:\n\nDoes RIC improve the Diabetic Retinopathy Severity Score (DRSS) after one year of treatment? Does RIC reduce the incidence of vision-threatening proliferative diabetic retinopathy (PDR)? What are the changes in retinal neurovascular unit parameters, visual acuity, and retinal oxygen saturation after RIC treatment?\n\nParticipants will:\n\nUndergo RIC therapy using a specialized device on both upper limbs (or a placebo intervention for the control group) for 1 year.\n\nComplete 5 cycles of RIC or placebo treatment twice daily, 5 days per week. Receive routine care for diabetic retinopathy as per clinical guidelines.\n\nKey outcome measures:\n\nPrimary outcome: Change in DRSS from baseline after one year. Secondary outcomes: Incidence of PDR, changes in visual acuity, retinal neurovascular unit measures, retinal oxygen saturation, and serum biomarkers (e.g., VEGF, CRP, IL-6).\n\nThis randomized, double-blind, placebo-controlled trial aims to recruit 68 participants to ensure 60 complete the study, accounting for a 13% dropout rate. The findings are expected to provide insights into RIC as a novel intervention for NPDR, reducing blindness risk and supporting future large-scale trials.",[112,27,113,114,115],"Diabetic Retinopathy","Remote Ischemic Conditioning","Diabetes Mellitus, Type 2","Randomized Controlled Trial",[27,112,117,113,115],"Retinal Neurovascular Unit","2025-06-22",{"date":120,"type":33},"2025-06-26",{"date":122,"type":33},"2025-04-20",{"date":124,"type":21},"2026-05-31",{"name":126,"class":127},"Xuxiang Zhang, MD","OTHER",2,"Non Proliferative Diabetic Retinopathy"]