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临床试验/NCT01628354
NCT01628354已完成4 期

A Study to Investigate the Safety and Efficacy of Lucentis (Ranibizumab) in Patients With CNV Due to Causes Other Than AMD and in Patients Where Pigment Epithelial Detachments Are the Primary Manifestation of Their AMD.

University of Melbourne2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2008年2月1日最近更新:
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试验速览

阶段
4 期
状态
已完成
入组人数
49
试验地点
2
主要终点
Mean change from baseline in best corrected visual acuity
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to causes other than age related macular degeneration (AMD) and pigment epithelial detachments (blisters of fluid under the retina) secondary to AMD with ranibizumab (Lucentis).

These groups of patients have to date been excluded from the multicentre trials demonstrating significant benefit of Ranibizumab in the treatment of AMD.

详细描述

Hypothesis

  1. That it is safe to treat patients with choroidal neovascularisation (CNV) secondary to causes other than age related macular degeneration (AMD) with ranibizumab
  2. That treatment of CNV secondary to causes other than AMD with ranibizumab is effective
  3. That treatment of pigment epithelial detachments (PEDs) secondary to CNV from AMD with ranibizumab is safe
  4. That treatment of pigment epithelial detachments (PEDs) secondary to CNV from AMD with ranibizumab is effective

Objectives

The primary objectives of this study are:

  • to investigate the medium term safety and efficacy of Ranibizumab in the treatment of CNV secondary to causes other than AMD (eg. angioid streaks, pseudoxanthoma elasticum, trauma, macular dystrophies, ocular inflammation/choroiditis and idiopathic causes).
  • to investigate the medium term safety and efficacy of Ranibizumab in the treatment of PEDs that are secondary to CNV from AMD

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patients presenting with choroidal neovascular membrane secondary to causes other than AMD or patients with Pigment epithelial detachments secondary to AMD where there is demonstrated progression of the disease.
  • •Total lesion area < 12 disc areas.
  • •Total area of CNV within the lesion must be > 50% of total lesion area in the first category of recruits, but not in those with PEDs.
  • •Best corrected visual acuity of 20/40 to 20/320 in the study eye.
  • •Willing and able to give informed consent

排除标准

  • •Prior treatment in the study eye with, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy or other anti VEGF treatments.
  • •History of submacular surgery or other surgical intervention in the study eye, glaucoma filtration surgery, corneal transplant surgery,
  • •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding baseline,
  • •Extracapsular extraction of cataract with phacoemulsification within three months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis, etc.),
  • •History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication),
  • •Aphakia with absence of the posterior capsule in the study eye,
  • •Active intraocular inflammation (grade trace or above) in the study eye,
  • •Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye,
  • •Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye,
  • •Presence of a retinal pigment epithelial tear involving the macula in the study eye,
  • •Subfoveal fibrosis or atrophy in the study eye.

结局指标

主要结局

Mean change from baseline in best corrected visual acuity

时间窗: 12 months

次要结局

  • Mean number of ranibizumab injections required over 12 months(12 months)
  • Mean change from baseline in retinal thickness(12 months)
  • Ocular and systemic adverse events(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robyn Guymer

Professor Robyn Guymer, Head Macular Research Unit, Department of Ophthalmology.

University of Melbourne

研究点 (2)

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