A 24-week, Randomized, Single-masked, Multicenter, Phase IV Study to Compare sysTemic VEGF Levels Following Monthly Intravitreal Injections of 0.5 mg Ranibizumab Versus 2 mg Aflibercept Until Week 24 in Patients With Visual Impairment DuE to Diabetic Macular Edema (TIDE DME).
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Area under the curve (AUC) of VEGF-A levels from baseline to week 24
研究概览
简要总结
The purpose of the study is to compare the effect of intravitreal injections of ranibizumab and aflibercept on systemic VEGF levels in DME patients in a detailed time course.
详细描述
The purpose of the study is to compare the effect of monthly intravitreal injections of 0.5 mg ranibizumab and 2.0 mg aflibercept on systemic VEGF levels in patients with visual impairment due to DME over a 24 week period. In addition, the study will also assess the effect on systemic VEGF-A levels when patients are switched from aflibercept to ranibizumab.
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 (Participant)
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
- •Type 1 or Type 2 diabetes mellitus
- •Visual impairment due to DME
- •BCVA of 78 to 24 (20/32-20/320) ETDRS letters
排除标准
- •Stroke or myocardial infarction less than 3 months prior to screening.
- •Presence of uncontrolled systolic blood pressure or diastolic blood pressure
- •Renal failure requiring dialysis or renal transplant or renal insufficiency
- •Untreated diabetes mellitus
- •Use of any systemic anti-VEGF drugs within 6 months prior to screening.
- •Use of systemic or inhaled corticosteroids for at least 30 consecutive days within 3 months prior to screening.
- •Women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception
- •For either eye:
- •Any active periocular or ocular infection or inflammation
- •Uncontrolled glaucoma
- •Neovascularization of the iris or neovascular glaucoma
- •History of treatment with any anti-angiogenic drugs
- •For study eye:
- •Atrophy or fibrosis involving the center of the fovea at the time of screening or baseline.
- •Cataract (if causing significant visual impairment), planned cataract surgery during the study period, vitrectomy, aphakia, glaucoma surgery, severe vitreous hemorrhage, rhegm
- •Irreversible structural damage within 0.5 disc diameter of the center of the macula
- •Panretinal laser photocoagulation within 6 months prior to randomization.
- •Focal/grid laser photocoagulation within 3 months prior to randomization.
- •Any intraocular procedure (including cataract surgery, Yttrium-Aluminum-Garnet capsulotomy) within 3 months prior to baseline or anticipated within the next 6 months following
- •Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months prior to screening.
- •Application of intravitreal corticosteroids in vitreous within 6 months prior to screening. Prior application of fluocinolonacetonid releasing implant in vitreous within 36 months prior to screening.
- •For fellow eye
- •Retinal or choroidal neovascularization or macula edema of any cause Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Group 1
Monthly intravitreal injections of 0.5 mg ranibizumab for six months
干预措施: Ranibizumab (Drug)
Group 2
Monthly intravitreal injections of 2 mg aflibercept for the initial three months followed by monthly intravitreal injections of 0.5 mg ranibizumab for the next three months.
干预措施: Ranibizumab (Drug)
Group 2
Monthly intravitreal injections of 2 mg aflibercept for the initial three months followed by monthly intravitreal injections of 0.5 mg ranibizumab for the next three months.
干预措施: Aflibercept (Drug)
Group 3
Monthly injections of 2 mg aflibercept for six months
干预措施: Aflibercept (Drug)
结局指标
主要结局
Area under the curve (AUC) of VEGF-A levels from baseline to week 24
时间窗: baseline to week 24
Systemic VEGF-A levels following monthly intravitreal injections of 0.5 mg ranibizumab versus 2 mg aflibercept (Area under the curve) expressed in pg/ml\*days. The AUC will be standardized (=divided) by the individual follow-up time and will be calculated by the trapezoidal rule..
次要结局
- Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 2 within specific time points(Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24)
- Mean Systemic VEGF-A levels in serum for patients in treatment group 1 and treatment group 3 within specific time points(Day 7, Day 15, Week 4, week 8, week 12, week 14, week 16, week 18, week 20, week 24)
- Proportion of patients reporting ocular and/or systemic adverse events in all the three treatment groups.(From Baseline to Week 24)