CTRI/2024/02/063012招募中1 期
A prospective, multi-centre, open label, single-arm, phase I study to evaluate the safety of GBL1204 in patients with neovascular age-related macular degeneration - NI
试验速览
- 阶段
- 1 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male or female subjects of age = 50 years.
- •2.Active primary or recurrent sub-foveal lesions with classic or occult choroidal neovascularization (CNV) secondary to wet AMD in the study eye, as confirmed by fluorescein angiography (FA).
- •3.Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye.
- •4.Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
- •5.Menopausal females must have experienced their last period at least 12 months prior to study entry to be classified as not of childbearing potential. Women of child-bearing potential and men must be practicing effective contraception implemented during the trial and for the remaining duration of the study
排除标准
- •1.Any active or significant ocular disease, ocular disorders, or conditions, such as diabetic retinopathy, retinal vascular occlusion etc. in the study eye other than wet AMD.
- •2.CNV in either eye due to other causes, such as diabetic retinopathy, ocular histoplasmosis, trauma, or pathologic myopia.
- •3.History of sub macular surgery or other surgical intervention for AMD, previous intravitreal drug delivery or vitrectomy surgery in the study eye.
- •4.Intraocular surgery (including cataract surgery) within 2 months in the study eye prior to enrolment.
- •5.History of retinal pigment epithelial tear, rhegmatogenous retinal detachment or macular hole (Stage 3 or 4), aphakia or absence of the posterior capsule in the study eye.
- •6.Current vitreous haemorrhage, subretinal haemorrhage that involves the fovea, subfoveal fibrosis or atrophy, active intraocular inflammation, or infection in the study eye.
- •7.Treatment with verteporfin photodynamic therapy in the study eye within 6 months or in the non-study eye within 1 week prior to enrolment.
- •8.Previous external-beam radiation therapy, trans-pupillary thermotherapy or subfoveal focal laser photocoagulation in the study eye.
- •9.Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month prior to screening.
- •10.Received anti-VEGF treatment for wet AMD within 3 months prior to screening.
- •11.Uncontrolled glaucoma (defined as intraocular pressure of 25 mmHg or more despite treatment with antiglaucoma medications) or history of glaucoma filtering surgery in the study eye.
- •12.Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either require medical or surgical intervention during the study period, or that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy.
- •13.Subject with history of idiopathic or autoimmune-associated uveitis in either eye.
- •14.Subjects with active eye infections such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •15.Subjects with controlled or uncontrolled diabetes mellitus.
- •16.Subjects receiving anticoagulant therapy.
- •17.PT and a PTT > 1.5 times of ULN.
- •18.Subjects test positive for HIV, HBsAg, HCV.
- •19.Stroke or myocardial infarction within 6 months prior to study drug administration, uncontrolled hypertension (systolic blood pressure =160 mmHg, or diastolic blood pressure =100 mmHg), etc.
- •20.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more than twice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times more than the ULN and is clinically significant in the opinion of the Investigator.
- •21.Pregnant and lactating women and those who cannot take contraceptive measures.
- •22.Known allergy to any component of the study intervention or history of allergy to fluorescein (only for subjects who have to undergo FA examination for diagnosis purposes) or any anaesthetics or antimicrobial agents used during the course of the study.
- •23.Likely candidate for intraocular surgery (including cataract surgery) in the study eye during the clinical trial.
- •24.Hypersensitivity to study drug or any of the excipients in study medication, or history of allergy to fluorescein.
- •25.Currently enrolled or participation in any clinical study of
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