EUCTR2009-015586-31-GB进行中（未招募）不适用
A Multicenter, Masked, Randomized, Sham-Controlled, Parallel-Group, 3 Month Study with a 9-Month Safety Extension to Evaluate the Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS®) Applicator System in Improving Visual Function in Patients with a Previous Rhegmatogenous Macula-Off Retinal Detachment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female age = 18 years
- •2. The macula-off retinal detachment (including fovea) must have been rhegmatogenous in etiology; no suspected combined mechanism is permitted in the study eye
- •3. The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
- •4. No evidence of macular detachment or macular edema on screening optical coherence tomography (OCT) in the study eye
- •5. The best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score must be = 24 letters (ie, approximately 20/320 or better) and = 65 letters (ie, approximately 20/50 or worse) in the study eye at screening and Day 1 and, in the opinion of the investigator, the decreased visual acuity is due to rhegmatogenous macula-off (including fovea) retinal detachment
- •6. The best-corrected ETDRS visual acuity in the non-study eye at screening is = 24 letters (approximately 20/320 or better)
- •7. The repair of the detachment must have been deemed an anatomic success, and must have required no more than one macular re-attachment procedure (at least 6 months before the Day 1 visit) in the study eye
- •8. Media clarity, pupillary dilation, and patient cooperation sufficient for adequate clinical evaluation of posterior pole and for adequate visualization of DDS® in the study eye
- •9. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment on Day 1. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilized
- •10. Written informed consent has been obtained
- •11. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained
- •12. Written Data Protection Consent (European sites only) has been obtained
- •13. Written documentation has been obtained in accordance with state and country privacy requirements, where applicable
- •14. Ability to understand the informed consent and willingness to follow study instructions and likely to complete all required visits and procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any sight-threatening ocular condition in the study eye other than RRD such as age-related macular degeneration, proliferative vitreo-retinopathy, moderate to severe diabetic retinopathy, epiretinal membrane or glaucoma requiring treatment that can interfere with the diagnosis or the assessment of disease progression or in the opinion of the investigator would prevent a 15-letter improvement in visual acuity
- •2. Silicone oil in the vitreous cavity of the study eye
- •3. Residual subretinal fluid in the macula or macular edema in the study eye by OCT or clinical exam
- •4. Cataract in the study eye defined as likely to:
- •a. require cataract surgery during the study or
- •b. contribute to worsening BCVA during the study or
- •c. prevent a 3-line improvement
- •5. Aphakia or presence of anterior chamber intraocular lens in the study eye
- •6. Anticipated need for ocular surgery in the study eye during the 12-month study period
- •7. Any injectable, periocular, or intravitreal corticosteroid treatment to the study eye within 6 months prior to screening (eg, triamcinolone acetonide) or any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
- •8. Any infectious condition in the study eye
- •9. Use of brimonidine, apraclonidine, or any other topical alpha-2 agonist in the study eye within 2 weeks prior to the screening visit or anticipated use during the study
- •10. Use of systemic alpha-2 antagonists (eg, phentolamine, phenoxybenzamine, yohimbine, idazoxan) or systemic alpha-2 agonists (eg, clonidine) within 2 weeks prior to the screening visit or anticipated use during the study
- •11. Sight-threatening disease in the non study eye
- •12. Known allergy to brimonidine tartrate or any component of the delivery vehicle or diagnostic agents used during the study (eg, dilation drops).
- •13. Contraindication to pupil dilation in either eye
- •14. Uncontrolled systemic disease
- •15. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
- •16. Any condition or reason (including inability to read ETDRS chart or language barrier) that precludes the patient’s ability to comply with study requirements including completion of the study
- •17. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to the screening visit
- •18. Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
研究者
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