EUCTR2010-021291-29-IT进行中（未招募）不适用
A 6-month, Phase II, Double-masked, Multicenter, Randomized, Placebo controlled, Parallel Group Study to Assess the Safety and Efficacy of Topical Administration of Two Concentrations of FOV2304 (1% and 2%) Twice Daily for the Treatment of Center-involving Clinically Significant Macular Edema Associated with Diabetic Retinopathy
FOVEA PHARMACEUTICALS0 个研究点目标入组 261 人开始时间: 2012年3月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 261
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. Written, signed informed consent obtained 3. Diagnosis of diabetes mellitus 4. Patient must be able to self administer study drug. 5. Clinically significant diabetic macular edema in at least one eye (â??study eyeâ?) involving the center of the macula. 6. Mild to severe non proliferative diabetic retinopathy 7. BCVA score >=34 letters and < 80 letters in the study eye 8. Female patients at least 1 year postmenopausal, surgically sterile or practicing two medically acceptable method of contraception. Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study. 9. Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 183
排除标准
- •1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity (including but not limited to severe macular ischemia, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition) 2. Proliferative diabetic retinopathy in the study eye 3. History of panretinal scatter photocoagulation (PRP) in the study eye within 4 months prior to screening, and/or anticipated need for PRP in the 3 months following randomization 4. Presence of any other condition in the study eye which could be contributing to macular edema: a. Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid macular edema or any other condition in the study eye which could be contributing to macular edema b. Presence of an epiretinal membrane, posterior hyaloidal traction, or vitreomacular traction in the study eye which, in the opinion of the investigator or central reading center, is the primary cause of macular edema, or is severe enough to prevent improvement in visual acuity despite reduction in macular edema. 5. Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye. 6. History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening 7.History of use of intravitreal injectable or periocular depot corticosteroids (other than triamcinolone acetonide) within 3 months prior to the screening visit in the study eye. 8. Patients who have previously received triamcinolone acetonide in the study eye. 9. Patients who have previously received anti-vascular endothelial growth factor (VEGF) therapy: a) Intravitreal anti-VEGF in the study eye within 3 months prior to the screening visit and/or b) Systemically within 3 months prior to the screening visit. 10. Uncontrolled glaucoma or glaucoma treated by 2 or more medications 11. Aphakia or intraocular lens placement in the anterior chamber of the study eye 12. Intraocular pressure (IOP) = 25 mmHg in the study eye on aplanation tonometry at screening visit. 13. Patients whose cumulative baseline corneal fluorescein staining score (i.e. sum of scores for all 5 corneal regions) for the study eye is graded as =5, or whose baseline corneal fluorescein staining score in any single region for the study eye is graded as =3 14. Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye 15. History of herpetic infection in either eye 16. History of corneal pathology/surgery 17. Contact lens use at any time during the study. Systemic conditions: 18. Uncontrolled systemic disease 19. Poorly controlled diabetes mellitus 20. Impaired renal function 21. Initiation/change of medical therapy for diabetes mellitus or hypertension within 4 months prior to screening, or planned change in the 4 months following inclusion in the study 22. Poorly controlled arterial hypertension 23. Use of systemic steroids within 1 month prior to the screening visit or anticipated use at any time during the study. 24.Concurrent participation in another clinical trial or treatment with any IMP within 3 months prior to inclusion in the study
研究者
相似试验
进行中（未招募）
1 期
A study to compare the safety and effectiveness of two concentrations of FOV2304 to placebo in the treatment of diabetic macular edema.Clinically significant diabetic macular edema in at least one eye involving the center of the maculaMedDRA version: 14.0Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disordersEUCTR2010-021291-29-BEFovea Pharmaceuticals SA261
进行中（未招募）
不适用
A study to compare the safety and effectiveness of two concentrations of FOV2304 to placebo in the treatment of diabetic macular edema.EUCTR2010-021291-29-DEFovea Pharmaceuticals SA261
进行中（未招募）
不适用
A study to compare the safety and effectiveness of two concentrations ofFOV2304 to placebo in the treatment of diabetic macular edema.Clinically significant diabetic macular edema in at least one eye involving the center of the maculaMedDRA version: 14.0Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disordersEUCTR2010-021291-29-CZFovea Pharmaceuticals SA261
进行中（未招募）
1 期
A phase II, Multicenter, Randomised, Double-Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects with Uncomplicated Acute Influenzancomplicated Acute InfluenzaMedDRA version: 8.1 Level: LLT Classification code 10059637 Term: Influenza antibody testEUCTR2006-005196-17-GBBioCryst Pharmaceuticals, Inc.300
招募中
2 期
To evaluate the efficacy of peramivir administered intramuscularly compared to placebo in adult subjects with uncomplicated acute influenza.ncomplicated influenza.Uncomplicated influenza.Respiratory - Other respiratory disorders / diseasesACTRN12607000284460BioCryst Pharmaceuticals Inc300