NCT00915837已完成1 期
Phase 1 Prospective, Randomized, Double-Masked, Multicenter Study to Evaluate the Safety and Tolerability of Two Dose Levels of the Helical Intravitreal Triamcinolone Implant in Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
This Phase 1 study will evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema over a three-year period.
详细描述
The Helical Intravitreal Triamcinolone Implant is intended to provide sustained release of triamcinolone acetonide into the vitreous chamber of the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically observable macular edema associated with diabetic retinopathy in study eye
- •Macular edema in study eye is associated with
- •visual acuity of 20/40 or worse; and
- •retinal thickening in the fovea as seen on biomicroscopic examination
- •angiographic evidence of leakage involving the perifoveal capillary net
- •Failure of macular edema to improve with prior macular photocoagulation, or the patient is unlikely to benefit from macular photocoagulation in the opinion of the investigator
- •Patients must be 18 years of age and older
- •Patients must be willing and able to return for scheduled follow up examinations for 3 years after initial surgery.
- •Patients must sign and be given a copy of the written Informed Consent form.
排除标准
- •Monocular, or vision worse than 20/400 in the fellow eye
- •Visual acuity worse than 20/200 20/200 and < 34 letters read in the study eye
- •Use of depot periocular steroids in the study eye within the past 30 days
- •Current use of >15 mg/day of oral steroids
- •Known steroid responder
- •Ocular hypertension > 22 mmHg in the study eye or need for more than one medication to maintain IOP < 22 mmHg.
- •Cup to disc ratio of > 0.8 in the study eye
- •Prior filtration surgery or glaucoma implant surgery in the study eye
- •Any active ocular infection in either eye
- •History of herpetic ocular infection in the study eye
- •Macular ischemia, defined as angiographic evidence of enlargement of the foveal avascular zone to 1 disc area or larger, centered on the fovea
- •Macular or panretinal photocoagulation treatment in the study eye within the past 90 days; laser capsulotomy within the past 90 days
- •Planned or known need for ocular surgery in the study eye within 90 days after enrollment and treatment
- •Any condition that precludes the subject's ability to comply with study requirements, including examinations or the completion of the study; or any condition that precludes the examiner's ability to obtain reliable fundus photography, angiography, or OCT images
- •Females who are pregnant or lactating, and premenopausal females who are unwilling to use a medically accepted method of birth control for the duration of the study
- •Participation in another investigational trial within 30 days prior to enrollment or during the study period
- •Uncontrolled hypertension (systolic BP > 160 mm Hg and/or diastolic BP > 90 mmHg)
- •Uncontrolled diabetes (HbA1c > 13)
- •Chronic renal failure requiring dialysis or anticipated renal transplant
- •Retinal or choroidal neovascularization in the study eye; anticipated need for panretinal photocoagulation within the next 30 days
- •Macular edema in the study eye known to be due to a cause other than diabetic retinopathy
- •Use of immunosuppressant drugs
研究组 & 干预措施
Slow release formulation
Experimental
Slow release formulation, helical intravitreal triamcinolone implant
干预措施: triamcinolone acetonide (Drug)
fast release formulation
Experimental
fast release formulation, helical intravitreal triamcinolone implant
干预措施: triamcinolone acetonide (Drug)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: every 3 months for 36 months
次要结局
- OCT(every 3 months for 36 months)
- Adverse events(every 3 months for 36 months)
- Fluorescein angiography(every 3 months for 36 months)
- IOP(every 3 months for 36 months)
- Slit lamp exam/funduscopy(every 3 months for 36 months)
研究者
研究点 (4)
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