CTRI/2023/09/057394已完成1 期
A perspective, multi-center, open label, single arm, phase 1 clinical study to evaluate the safety of R-TPR-023 in patients with neovascular (wet) age-related macular degeneration. - NI
Reliance life sciences0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
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 classic or occult 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. Menopausal females must have experienced their last period at least 12 months prior
- •to study entry to be classified as not of childbearing potential. Men and women of child
- •bearing potential must be practicing effective contraception implemented during the
- •trial and for at least 60 days following the last dose of study medication.
排除标准
- •1. Treatment with verteporfin photodynamic therapy in the study eye within 6 months or
- •in the non-study eye within 1 week prior to randomization.
- •2. Previous external-beam radiation therapy, trans-pupillary 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 randomization.
- •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. Any significant retinal disease other than neovascular AMD such as diabetic
- •retinopathy, retinal vascular occlusion etc.
- •9. 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
- •10. Intraocular surgery (including cataract surgery) within 2 months in the study eye prior
- •to enrolment
- •11. 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
- •12. Presence of/history of idiopathic or autoimmune-associated uveitis in either eye.
- •13. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- •14. Patients with controlled or uncontrolled diabetes mellitus.
- •15. Patients receiving anticoagulant therapy.
- •16. PT and aPTT > 1.5 times of ULN
- •17. Patients who are HIV, HBsAg, HCV test positive.
- •18. Pregnancy or lactation.
- •19. Prior use of study medication bevacizumab
- •20. Use of any other anti-VEGF agents within 3 months or 5 half-lives whichever is longer
- •21. Hypersensitivity to study drug or any of the excipients in study medication, or history
- •of allergy to fluorescein.
- •22. Participation in any clinical study of an investigational product within previous 3
- •23. 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.
- •24. 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.
研究者
相似试验
已完成
4 期
Safety Surveillance Study of BCG vaccineCTRI/2017/09/009844GreenSignal BioPharma Private Limited3,500
尚未招募
4 期
Safety Study on BCG Vaccine of GreenSignal Bio Pharma Pvt Ltd.CTRI/2023/02/049985GreenSignal Bio Pharma Pvt. Ltd.
已完成
4 期
Post Market Study to Evaluate the Safety & Efficacy of product UrgoClean Ag in the Management of Diabetic Foot UlcersCTRI/2020/12/029670Eucare Pharmaceuticals Private Limited60
尚未招募
4 期
se Of Amlapitta Mishran suspension in treatment of Amlapitta (Hyperacidity)CTRI/2022/05/042670Shree Dhootapapeshwar Limited
已完成
2 期
Clinical study on Ampop tablet in healthy participants.CTRI/2023/03/050976Transformative Learning Solutions Private Limited