CTRI/2024/12/077904招募中3 期
A Phase III Prospective, Randomized, Open-labelled, Blinded endpoint (PROBE), Multi-centric, Parallel Group, Non-inferiority Study to compare the Efficacy and Safety of GBL1204 with Ranibizumab in Patients with Wet Age-Related Macular Degeneration (PROMISES Study)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 36
- 主要终点
- Mean change in best corrected visual acuity (BCVA) in subjects in both groups.
研究概览
简要总结
This is a prospective, randomized, open-labelled, blinded endpoint (PROBE), multi-centric, parallel-group, two-arm, interventional, non-inferiority study designed to compare efficacy and safety of GBL1204 with ranibizumab. The study will enroll 308 adult subjects (age equal to or more than 50 years) diagnosed with wet AMD (154 per treatment arm), confirmed by Fluorescein angiography. The total study duration for each subject will be approximately 18 weeks, including a screening period of up to 10 days, a 12-week treatment period, and a 1-month follow-up period (week 16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult male or female subjects of age equal to or more than 50 years including non-diabetics or subjects with controlled diabetes with prescribed medication who are capable of understanding and giving written informed consent 2.Subjects with a diagnosis of wet AMD confirmed by fluorescein angiography showing the presence of active subfoveal choroidal neovascularization CNV This includes, a.newly diagnosed active CNV lesion or b.previously untreated active CNV lesion or c.subjects with prior treatment of the active CNV lesion at least three months before the enrolment Active CNV is defined as any leakage detected on FA 3.Total lesion area less than or equal to 12.0 Disc Areas DA in size in the study eye 4.BCVA between 20/320 to 20/40 Snellen equivalent both value inclusive in the study eye before pupil dilation assessed using the ETDRS visual acuity charts 5.Women of non-childbearing potential i e postmenopausal for at least 12 months prior to trial entry, or surgically sterile OR if of childbearing potential a pregnancy test with a negative result must be obtained prior to the first treatment Women of childbearing potential must practice effective contraception during the trial and for at least 60 days following the last dose of the study injection 6.No known contraindication to intravitreal injection of GBL1204 or ranibizumab 7.Willing and able to undertake all scheduled visits and assessments.
排除标准
- •1.Subjects with the presence of other significant ocular disorders in the study eye affecting visual acuity, such as:Sub-retinal hemorrhage covering more than 50% of the total lesion area involving the center of the fovea as assessed by FA, scar, fibrosis, or atrophy, involving the center of the fovea, making up more than 50 percent of the total lesion as assessed by FA, retinal pigment epithelial tear involving the macula, presence of a macular hole at any stage, uncontrolled glaucoma (intraocular pressure exceeding 25 mmHg despite treatment) or any other retinal or macular abnormality (other than AMD) that could affect central vision or the efficacy assessments in the study eye.
- •2.The presence of CNV in the study eye due to other causes, such as ocular histoplasmosis, trauma, angioid streaks, choroidal rupture, pathologic myopia (spherical equivalent of -8.0 diopters or more, or axial length of 25 mm or more), or multifocal choroiditis.
- •3.Subjects who, in the opinion of the principal investigator (PI), may require medical or surgical intervention within 4 to 5 months of study period, or for whom the decision to prevent surgery or treatment would lead to a loss of best corrected visual acuity during the study period.
- •4.Subjects, who are unable to be photographed to document CNV, due to known allergy to fluorescein dye, lack of venous access, or cataracts obscuring the CNV.
- •5.Subject with dense corneal and lens opacities, obstructing the view of central retina.
- •6.Known hypersensitivity to the components of the study medication (bevacizumab or ranibizumab).
- •7.Previous treatment with verteporfin PDT, Macugen, ranibizumab, intravitreal Avastin®, thermal laser, external beam radiation, intravitreal steroids, or other AMD therapy in the study eye (except for extrafoveal laser photocoagulation) as well as the contralateral non-study eye within past 3 months before enrolment in the study.
- •8.Laser photocoagulation in the study eye within 1 month prior to enrolment in the study.
- •9.Concurrent or any prior use of systemic anti-vascular endothelial growth factor (VEGF) agents.
- •10.Concurrent treatment with an investigational drug or any medical device in the either eye or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational drug or device study(ies) prior to enrolment.
- •11.History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME), or any other vascular disease affecting the retina, other than AMD, in either eye.
- •12.History of vitrectomy, any vitreous hemorrhage, rhegmatogenous retinal detachment, or macular hole in the study eye.
- •14.Active intraocular inflammation including scleritis or active or suspected ocular or periocular infection in either eye (including infectious conjunctivitis, keratitis, scleritis, uveitis, or endophthalmitis), within 2 weeks prior to randomization.
- •15.History of any intraocular or periocular surgery (including cataract surgery) in the study eye within 2 months prior to enrolment in the study.
- •16.Having corneal transplant in the study eye.
- •17.Presence or history of scleromalacia in either eye.
- •18.For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.
- •19.Subjects who used coumarin derivatives at the time of inclusion.
- •20.Subjects with immunocompromised status including seropositivity for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or any other serious uncontrolled concomitant immunodeficiency.
- •22.Subjects with uncontrolled hypertension (blood pressure exceeding 160/100 mmHg) and uncontrolled diabetes (HbA1c more than 8 percent).
- •23.Subjects with a history or presence of concurrent systemic diseases or metabolic dysfunctions or abnormal physical examination or clinical laboratory finding that raises reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for treatment complications based on the Principal Investigator’s discretion such as: cardiovascular disease, uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic (e.g., optic neuropathy), metabolic, pulmonary, or autoimmune disease based on previous history and relevant reports of clinical examination, laboratory tests, or electrocardiogram, etc.
- •24.Subjects with a history of recurrent significant infections or bacterial infections or subjects undergoing treatment for active systemic infection.
- •25.Any psychological, familial, sociological, geographical, or other condition that would preclude study compliance and follow-up.
- •26.Previous participation in any other trial within the last 3 months prior to enrolment in this trial 27.The subject is not suitable to participate in the study at the discretion of the Principal Investigator.
结局指标
主要结局
Mean change in best corrected visual acuity (BCVA) in subjects in both groups.
时间窗: Baseline to Week 16
次要结局
- Efficacy(Proportion of subjects who gained 15 letters or more on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.)
研究者
研究点 (36)
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