CTRI/2021/06/033972已完成4 期
A prospective, multi-center, single arm, open label, study to evaluate safety and efficacy of RanizuRelTM containing Ranibizumab for intra-vitreal injection, manufactured by Reliance Life Sciences, Pvt. Ltd. India in patients with neovascular (wet) age-related macular degeneration.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
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 patients of age = 50 years.
- •2. Active primary or recurrent subfoveal lesions with choroidal neovascularization (CNV)
- •secondary to age-related macular degeneration (AMD) in the study eye.
- •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. Men and women of childbearing potential must be using adequate birth control
- •measures, as discussed with the study doctor. Menopausal females must have
- •experienced their last period more than 12 months prior to study entry to be classified
- •as not of childbearing potential.
排除标准
- •1. Treatment with verteporfin photodynamic therapy in the study eye within 6 months or
- •in the nonstudy eye within 1 week prior to enrolment.
- •2. Previous external-beam radiation therapy, transpupillary thermotherapy or subfoveal
- •focal laser photocoagulation in the study eye.
- •3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month
- •prior to enrolment.
- •4. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
- •pathologic myopia.
- •5. History of submacular surgery or other surgical intervention for AMD, previous
- •intravitreal drug delivery or vitrectomy surgery in the study eye.
- •6. Current vitreous haemorrhage, subretinal hemorrhage that involves the fovea,
- •subfoveal fibrosis or atrophy, active intraocular inflammation or infection in the study
- •7. 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
- •8. Uncontrolled glaucoma (defined as intraocular pressure of 30 mmHg or more despite
- •treatment with antiglaucoma medications) or history of glaucoma filtering surgery in
- •the study eye
- •9. Intraocular surgery (including cataract surgery) within 2 months in the study eye prior
- •to enrolment.
- •10. 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 could likely contribute to loss of at least 2 Snellen equivalent lines of best
- •corrected visual acuity.
- •11. History of idiopathic or autoimmune-associated uveitis in either eye.
- •12. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •13. Patients with history of diabetes mellitus.with HbA1c >8% [64 mmol/mol]
- •14. Patients who are HIV, HBsAg, HCV test positive.
- •15. Patients with positive urine pregnancy test at screening.
- •16. Hypersensitivity to ranibizumab or any of the excipients, or history of allergy to
- •fluorescein.
- •17. Participation in any clinical study of an investigational product within previous 3
- •18. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic,
- •hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral
- •disease that renders the patient incapable of participating in the study.
- •19. History of other disease, active systemic infection, metabolic dysfunction, physical
- •examination finding, or clinical laboratory finding giving reasonable suspicion of a
- •disease or condition that contraindicates the use of an investigational drug or that
- •might affect interpretation of the results of the study or render the subject at high risk
- •for treatment complications.
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