EUCTR2009-016760-36-PT进行中（未招募）不适用
Prospective, randomized, open label phase II study to assess efficacy and safety of Macugen® (pegaptanib 0.3 mg intravitreal injections) plus panretinal photocoagulation (PRP) and PRP (monotherapy) in the treatment of patients with high risk proliferative diabetic retinopathy. -
AIBILI0 个研究点开始时间: 2009年11月26日最近更新:
适应症
相关药物
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. Type I, or Type II diabetic subjects as defined by the WHO criteria of either gender, and aged = 18 years.
- •2. Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
- •3. Ability to provide written informed consent.
- •4. Ability to return for all trial visits.
- •5. High-risk proliferative diabetic retinopathy (HR-PDR) eyes (as defined in section 2).
- •6. BCVA at baseline > 20/320 (25 letters in the ETDRS Chart) in the study eye.
- •7. Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.
- •8. Intraocular pressure < 21 mmHg
- •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. Eyes with prior scatter (panretinal)
- •2. Focal/grid photocoagulation, within the previous 6 months.
- •3. Fibrovascular proliferation with retinal traction.
- •4. Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
- •5. Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
- •6. Subjects who have received YAG laser within the previous 6 months.
- •7. Peripheral retinal cryoablation, or laser retinopexy (for retinal tears only),
- •8. Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
- •9. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
- •10. Any intraocular surgery within 6 months before trial enrolment.
- •11. Previous vitrectomy.
- •12. HbA1C level >11% or recent signs of uncontrolled diabetes.
- •13. Any of the following underlying systemic diseases:
- •History or evidence of severe cardiac disease, e.g. NYHA Functional Class III or IV, clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction, or revascularization procedure within 6 months prior to baseline, or ventricular tachyarrhythmia requiring treatment.
- •History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation.
- •Clinically significant impaired renal function (serum creatinine >2.5 mg/dL or s/p renal transplant or receiving dialysis).
- •Clinically significant impaired hepatic function.
- •Stroke (within 12 months of trial entry).
- •Any major surgical procedure within one month before trial enrolment.
- •14. Previous radiation to the head in the region of the study eye.
- •15. Any prior treatment with an investigational agent for diabetic retinopathy or anti-VEGF therapy (including intravitreal, subconjunctival or subtenons corticosteroids) during the past 90 days for any other condition.
- •16. Known serious allergies to fluorescein used in angiography, or to components of Macugen® formulation.
- •17. Systolic BP > 170 (2 different readings) or diastolic BP > 100 (2 different readings).
- •18. Acute ocular or periocular infection.
- •19. Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage devise (e.g., tube-shunt surgery).
- •20. Use of other investigational drugs at the time of enrollment.
- •21. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- •22. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •23. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
- •24. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices - IUDs). Periodic abstinence (e.g. calendar
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