Intravitreal Lucentis (iL) (Ranibizumab) for the Treatment of AMD Related Pigment Epithelial Detachment (PED)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To investigate whether iL given monthly for 6 months in patients with Predominantly PED lesions (secondary to AMD) will significantly improve mean visual acuity from baseline on a standardized ETDRS chart.
研究概览
简要总结
Patients with Pigment Epithelial Detachments secondary to Age-Related Macular Degeneration (AMD) will receive intravitreal Lucentis monthly for 6 months in the hope of improving visual acuity from a baseline evaluation.
详细描述
Background:
Exudative Age Related Macular Degeneration (AMD) results in a significant and severe visual loss if left untreated as documented in natural history and observational arms of studies such as the macular photocoagulation study (MPS) and the Tap and VIP study with Visudyne. It is also clear however, that the different lesion types (classified by intravenous fluorescein angiography ((IVFA)) as occult, minimally classic or predominately classic) have both a different natural history and a different response to treatment.
The recent introduction of the anti-VEGF agents such as Macugen and Lucentis have significantly advanced our ability to treat AMD as both agents show clear efficacy across all lesion subtypes regardless of lesion composition.
A clear absence of literature on clinical outcomes exist however for fibrovascular pigment epithelial detachments (PED). PED represents a form of exudative AMD which clearly behaves in a unique and distinctive manner when compared to the lesion(s) described above.
As standard exclusion criteria within most of the major AMD trials, lesion composition of any IVFA subtype is acceptable as long as less then 50% of the lesion is composed of blood or pigment epithelial detachment. This has resulted in a notable absence of clinical literature on the response of predominately PED type lesions to current standard of care anti-VEGF agents. In an effort to address this absence, a prospective evaluation of the response of predominately PED type lesions to Lucentis, the current gold standard therapy is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Predominantly PED type lesions as classified on IVFA and OCT secondary to AMD.
- •PED under the geometric center of the foveal avascular zone.
- •Evidence of recent disease progression as suggested by one or more of the following: sub-retinal lipid or cystic macular edema, sub-retinal hemorrhage, vision loss within the last 3 months or documented lesion growth on FA over previous 6 months.
- •Visual acuity of between 20/40 and 20/800 in the study eye - Equivalent to Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart score of 5 to 75 letters at 2 meters.
- •Ambulatory Vision in the fellow eye
- •Willingness and ability to participate and provide written informed consent.
排除标准
- •Individuals with choroidal neovascularization from causes other than AMD.
- •Patients physically unable to tolerate intravenous fluorescein angiography
- •Any intraocular surgery within 2 months in the study eye.
- •Prior retinal or vitreous surgery including vitrectomy or scleral buckling in the study eye.
- •Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome.
- •Individuals with physical or mental disabilities that prevent accurate vision testing.
- •History of treatment of CNVM in the study eyes other than extrafoveal confluent laser photocoagulation.
- •Prior photodynamic therapy for CNV.
- •Any patient with recent history of new onset cardiac disease or thromboembolic CNS event in the past.
- •Women of childbearing potential who are not on two forms of effective contraception during the trial and for at least 60 days following the last dose of study medication.
研究组 & 干预措施
Lucentis
All patients receive iL for for first 6 months of study. At 6 months - patients are classified as "responders" or "non-responders". "Responders" receive iL PRN based on OCT,clinical exam etc. "Non-responders" are seen again at 12 months for repeat investigations.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
To investigate whether iL given monthly for 6 months in patients with Predominantly PED lesions (secondary to AMD) will significantly improve mean visual acuity from baseline on a standardized ETDRS chart.
时间窗: 6 months
次要结局
- To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on lesion growth and activity over the study period.(6 months)
- To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions alone on contrast sensitivity.(6 months)
- To evaluate the effect of iL given monthly for 6 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT).(6 months)
- To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on lesion growth and activity over the study period.(12 months)
- To evaluate the effect of iL given for up to 12 months in patients with Predominantly PED lesions on central retinal thickness via Optical Coherence Tomography (OCT).(12 months)
研究者
Thomas G. Sheidow
Vitreoretinal Surgeon, Associate professor of Ophthalmology
Lawson Health Research Institute