EUCTR2014-000385-22-IT进行中（未招募）不适用
erve Growth Factor eye drops as a novel treatment for vision loss in patients with Retinitis Pigmentosa: from preclinical toclinical Phase II trial. - NEMO
Ospedale San Raffaele di Milano0 个研究点开始时间: 2014年5月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Patients between 18 and 60 years of age.
- •2. Patients with typical orms of RP characterized by the following
- •clinical features:
- •a) classic fundus appearance (i.e. intraretinal pigment deposits,thinning and atrophy of the RPE in the mid- and far peripheral retina, with relative RPE preservation in the macula, waxy
- •pallor of the optic disc, attenuation of the retinal vessels)
- •b) reduced and delayed ERG responses
- •c) visual field constriction
- •and/or atypical forms of RP:
- •The atypical form of RP is characterized by early onset (first decade) or syndromic forms of RP (eg paravenous sector pericentral or unilateral RP, Leber congenital amaurosis, Resfum disease, Usher syndrome, Bardet - Biedl, etc. ).
- •3. presence of macular edema documented by OCT (macular thickness greater than 250 um) lasting for at least 3 months and not in treatment for at least 1 month;
- •4 Best corrected distance visual acuity (BCDVA) between 20/100 (2/10 or 0.1 logMAR) and 20/25 (8/10 or +0.7 logMAR) , near vision lower than second character in either eye.
- •5. Absence of other confounding ocular diseases.
- •6. Only patients who satisfy all Informed Consent requirements may be
- •included in the study. The patient and/or his/her impartial witness must
- •read, sign and date the Informed Consent document before any
- •studyrelated procedures are performed. The Informed Consent form signed by patients and/or impartial witness must have been approved by the IEC for the current study.
- •7. Patients must have the ability and willingness to comply with study
- •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 45
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence of macular edema associated with diabetes , choroidal neovascularization or after eye surgery.
- •2 . Patients with diabetes mellitus
- •3 . History of any ocular surgery (including laser or refractive surgical
- •procedures) in either eye within the 90 days before study enrolment.
- •Ocular surgery will not be allowed during the study treatment period and
- •elective ocular surgery procedure.
- •4. Evidence of an active ocular infection.
- •5. History of uveitis or evidence of intraocular inflammation in either eye.
- •6. History or evidence of glaucoma or an IOP greater than or equal 21
- •mmHg in either eye at the time of study enrollment
- •7. Anterior segment abnormalities or media opacities obscuring the view
- •of the posterior pole in either eye.
- •8. Treatment with corticosteroids (systemic, periocular or intravitreal)
- •) in either eye within 90 days of study enrollment.
- •9. Use of any topical medication other than the study medication for the
- •treatment of ocular diseases with the exception of artificial tears during the study period.
- •10. Presence or history of any ocular or systemic disorder or condition
- •that might significantly limit visual acuity or the visual field, hinder the
- •efficacy of the study treatment or its evaluation, could possibly interfere
- •with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct of trail procedures.
- •11. Known hypersensitivity to one of the components of the study or
- •procedural medications.
- •12. Participation in another clinical study at the same time as the present study or within 90 days of screening/baseline visit.
- •13. History of drug, medication or alcohol abuse or addiction.
- •14. Females of childbearing potential (those who are not surgically
- •sterilized or post-menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
- •a. are currently pregnant or,
- •b. have a positive result on the urine pregnancy test at the Screening/Baseline Visit or,
- •c. intend to become pregnant during the study treatment period or,
- •d. are breast-feeding or,
- •e. not willing to use highly effective birth control measures, such as:
- •Hormonal contraceptives – oral, implanted, transdermal, or injected
- •and/or mechanical barrier methods – spermicide in conjunction with a
- •barrier such as a condom or diaphragm or IUD during the entire course
- •of and 30 days after the study treatment periods.
研究者
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