EUCTR2004-002502-29-HU进行中（未招募）不适用
A Six-Month, Phase 3, Multicenter, Masked, Randomized, Sham-Controlled Trial (with Six-Month Open-Label Extension) to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Macular Oedema following Central Retinal Vein Occlusion or Branch Retinal Vein Occlusion.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
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, at least 18 years of age
- •2. Macular edema in the study eye with all of the following characteristics:
- •-involving the center of the macula (fovea)
- •-due to BRVO or CRVO
- •-with a duration of 6 weeks to 9 months prior to qualification/baseline visit for
- •CRVO patients and a duration of 6 weeks to 12 months prior to
- •qualification/baseline visit for BRVO patients
- •-VA decrease attributable to the edema
- •-in the investigator’s opinion, unlikely to be adversely affected if not treated for 6
- •3. BCVA score between 34 letters (approximately 20/200 Snellen equivalent) and 68
- •letters (approximately 20/50 Snellen equivalent) in the study eye measured by the
- •ETDRS method at qualification/baseline
- •4. Retinal thickness of = 300 µm by OCT in the central 1 mm macular subfield of
- •the study eye at qualification/baseline as determined by the investigator
- •5. Female patients of childbearing potential must have a negative urine pregnancy
- •test at the randomization (day 0) visit
- •6. Written informed consent has been obtained
- •7. Written Authorization for Use and Release of Health and Research Study
- •Information (US sites only) has been obtained
- •8. Written Data Protection Consent (European sites only) has been obtained
- •9. Written documentation has been obtained, in accordance with state and country
- •privacy requirements, where applicable
- •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. Uncontrolled systemic disease
- •2. Any ocular condition in the study eye that, in the opinion of the investigator,
- •would prevent a 15-letter improvement in visual acuity (eg, severe macular
- •3. Presence of an epiretinal membrane in the study eye which, in the opinion of the
- •investigator, is the primary cause of macular edema, or is severe enough to
- •prevent improvement in visual acuity despite reduction in macular edema
- •4. History of IOP elevation in response to steroid treatment in either eye that
- •resulted in any of the following:
- •1) a = 10 mm Hg increase in IOP from baseline;
- •2) IOP = 25 mm Hg; or
- •3) required therapy with anti-glaucoma medications
- •5. History of glaucoma or optic nerve head change consistent with glaucoma
- •damage, and/or glaucomatous visual field loss in the study eye. Patients with a
- •history of previous angle-closure that has been successfully treated with either a
- •laser or surgical peripheral iridotomy (PI) are allowed as long as the visual fields
- •have been stable for > 1 year prior to study entry and the patient has been and can
- •be safely dilated.
- •6. Ocular hypertension in the study eye at qualification/baseline with any of the
- •1) IOP > 23 mm Hg if taking no anti-glaucoma medications;
- •2) IOP > 21 mm Hg if taking one anti-glaucoma medication; or
- •3) use of 2 or more anti-glaucoma medications (combination products should be
- •considered 2 medications)
- •Note: Anti-glaucoma medications or lack thereof must be stable for at least 4
- •weeks prior to qualification/baseline.
- •7. Aphakia or presence of anterior chamber intraocular lens in the study eye
- •8. Diabetic retinopathy in either eye
- •9. Active or history of choroidal neovascularization in the study eye
- •10. Presence of rubeosis iridis in the study eye at qualification/baseline
- •11. Any active ocular infection (ie, bacterial, viral, parasitic, or fungal) in either eye
- •at qualification/baseline
- •12. History of herpetic infection in the study eye or adnexa
- •13. Presence of active or inactive toxoplasmosis in either eye at qualification/baseline
- •14. Presence of visible scleral thinning or ectasia in the study eye at
- •qualification/baseline
- •15. Intraocular surgery, including cataract surgery, and/or laser of any type in the
- •study eye within 90 days prior to qualification/baseline
- •16. History of central serous chorioretinopathy in either eye
- •17. History of pars plana vitrectomy in the study eye
- •18. History of use of intravitreal steroids or any intravitreal injectable drug in the
- •19. Periocular depot of steroids to the study eye within 6 months prior to
- •qualification/baseline
- •20. Use of systemic steroids (e.g., oral, intravenous, intra-articular, epidural, intrabursal) within 1 month prior to qualification/baseline visit or anticipated use at
- •any time during the study. Inhaled and intranasal steroids are allowed.
- •21. Use of topical or systemic carbonic anhydrase inhibitors (e.g., Azopt®, Trusopt®,
- •Diamox®) within 1 month prior to qualification/baseline visit or anticipated use at
- •any time during the study
- •22. Use of immunosuppressants, immunomodulators, antimetabolites, and/or
- •alkylating agents use within 6 months prior to qualification/baseline or anticipated
- •use at any time during the study
- •23. Use of topical ophthalmic steroids or topical non-steroidal anti-inflammatory
- 另有 3 项未显示
研究者
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