NCT00576459已完成2 期
A Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Intravitreal Fluocinolone Acetonide (0.5mg and 2mg) Implants in Patients With Clinically Significant Diabetic Macular Edema
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Between group difference in mean visual acuity change (from baseline)
研究概览
简要总结
This is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal FA implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema.
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
- Single (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
- •Subjects with type 1 or 2 diabetes.
- •Subjects with clinically significant macular edema as defined by the ETDRS.
- •A best corrected visual acuity between +0.30 and +1.00 logMAR (70 and 35 letters or approximately 20/40 to 20/200) as measured on an ETDRS chart.
- •Subjects with laser treatment status/history as follows: [1] Naïve to laser photocoagulation or Focal laser photocoagulation more than 16 weeks prior to screening or PRP more than 24 weeks prior to screening, [2] No laser scars within 500µm (4x the width of a retinal vein at the disc margin) of the central macula.
- •The subject's ocular media had to be sufficiently clear to allow for quality fundus photography.
- •If aphakic or pseudophakic, lens removal had to have occurred at least 40 weeks prior to screening.
- •Subjects had to be males or non-pregnant females of at least 18 years.
- •Subjects had to display the ability and willingness to comply with treatment, follow up process, and sign an Informed Consent Form.
排除标准
- •Subjects who have had previous grid macular photocoagulation for diffuse macular edema.
- •Presence of posterior hyaloid membrane, epiretinal membranes, fibrovascular proliferation, and vitreopapillary traction, which causes tractional distortion on the macula as demonstrated by OCT or funduscopy.
- •History of or current retinal detachment requiring surgical treatment or a scleral buckle.
- •Diabetic Retinopathy that required immediate PRP.
- •Ocular disease other than diabetic retinopathy that could confound the outcome of the study (e.g., age-related macular degeneration, drug toxicity, uveitis, hypertensive retinopathy, ischemic maculopathy, etc.).
- •Glaucoma, or history of glaucoma in either the study eye or the fellow eye.
- •Ocular hypertension, or history of ocular hypertension requiring IOP lowering treatment.
- •A media opacity that precludes visualization and/or diagnosis of the status of the eye.
- •Concurrent coumadin therapy or known bleeding diathesis.
- •Subjects requiring chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to manage non-ocular disease.
- •Concurrent treatment with a new investigational drug.
- •Subjects with a best-corrected visual acuity worse than +1.0 logMAR (20/200 or 35 ETDRS letters) in the fellow eye.
- •Pregnant or lactating females.
- •Females of childbearing potential considering becoming pregnant during the course of the study and those not taking effective contraception/precautions to avoid pregnancy.
- •History of hypersensitivity to fluorescein, known allergies to steroids or any component of the intraocular device.
- •Subjects with photophobia that will preclude the ability to do fundus evaluations.
研究组 & 干预措施
Fluocinolone acetonide 0.59 mg
Experimental
0.59 mg fluocinolone acetonide intravitreal implant
干预措施: 0.59 mg fluocinolone acetonide intravitreal implant (Drug)
Fluocinolone acetonide 2.1 mg
Experimental
2.1 mg fluocinolone acetonide intravitreal implant
干预措施: 2.1 mg fluocinolone acetonide intravitreal implant (Drug)
Laser photocoagulation
Active Comparator
standard of care laser photocoagulation
干预措施: standard of care laser photocoagulation (Procedure)
结局指标
主要结局
Between group difference in mean visual acuity change (from baseline)
时间窗: 1 year
次要结局
- Differences in the proportions of subjects in each treatment group experiencing changes in: the area of retinal thickening; retinal leakage and cystoid scores; grade of diabetic retinopathy(1 year)
- Ocular adverse events, non-ocular adverse events, and intraocular pressure >/= 30 mm Hg(throughout study)
研究者
研究点 (2)
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