A Pilot Study to Determine if Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 12 Weeks for a Year After an Induction Phase of Three Injections Every 6 Weeks Will Reduce the Progression of Proliferative Diabetic Retinopathy in Patients Without Significant Vitreous Hemorrhage in Comparison to Treatment With Retinal Photocoagulation Alone and After an Induction Phase
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Establish efficacy of intravitreal pegaptanib sodium injections in causing regression of high risk proliferative diabetic retinopathy as compared to panretinal photocoagulation
研究概览
简要总结
Intravitreal injections of pegaptanib will induce the regression of Proliferative Diabetic Retinopathy (PDR) and reduce the need for retinal photocoagulation.
详细描述
Primary Objective:
To further establish the efficacy of intravitreal pegaptanib injections in the regression of retinal neovascularization secondary to high-risk PDR, as compared to standard panretinal photocoagulation (PRP)
Secondary Objective:
To maintain the regression of PDR after the induction phase with intravitreal pegaptanib injections administered at 12-week intervals, as compared to standard PRP
To maintain the regression of PDR after the induction phase with retinal photocoagulation applied to areas of ischemia (Selective Laser Photocoagulation), as compared to standard PRP
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Eligible eyes will have active PDR with high risk characteristics (HRC) as defined by the DRS. All eyes must meet at least one or both of the following criteria:
- •Mild neovascularization of the disc (NVD) of at least 1/4 to 1/3 disc area as shown in standard photograph 10A of the DRS.
- •Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc area as shown in standard photograph 7 of the DRS.
- •ETDRS visual acuity score greater than or equal to 24 letters (approximately 20/320) and less than or equal to 85 letters (approximately 20/20) by the ETDRS visual acuity protocol at the screening visit.
- •Eyes with mild pre-retinal hemorrhage (PRH) or mild vitreous hemorrhage (VH) that does not interfere with clear visualization of the macula and optic disc are eligible for this study.
- •Evaluating physician believes that PRP can be safely withheld for 3 weeks.
排除标准
- •Presence of moderate or dense PRH or VH that prevents clear visualization of the macula and/or optic disc.
- •Presence of either:
- •significant epiretinal membranes involving the macula, OR
- •proliferative diabetic membranes along the major retinal arcades that are extensive enough to cause either:
- •significant vitreomacular traction, OR
- •significant impairment in visual acuity.
- •Presence of any tractional retinal detachment.
- •Severe ischemia involving the foveal avascular zone as determined by fluorescein angiography performed at the initial screening visit.
- •Significant media opacity (due to cornea, anterior chamber, or lens) precluding clear visualization of the macula or optic disc.
- •Presence of neovascular glaucoma with or without hyphema.
- •Previous treatment with intravitreal steroid injections in the study eye within 6 months of baseline.
- •Previous treatment with peribulbar steroid injections in the study eye within 90 days of baseline
- •Previous PRP laser treatment in the study eye within 90 days of baseline visit.
研究组 & 干预措施
IV Macugen Q6
Will receive 3 intravitreal pegaptanib injections at 6-week intervals, then 3 additional injections at 12-week intervals
干预措施: Macugen ® (pegaptanib sodium) (Drug)
IV Mac Q6 Arm
Will Selective Laser Photocoagulation after 3 intravitreal pegaptanib injections
干预措施: Macugen ® (pegaptanib sodium) (Drug)
Pan Retinal Photocoagulation
Will act as the control group, thus subjects in this group will receive standard PRP (modified ETDRS protocol)
干预措施: Macugen ® (pegaptanib sodium) (Drug)
结局指标
主要结局
Establish efficacy of intravitreal pegaptanib sodium injections in causing regression of high risk proliferative diabetic retinopathy as compared to panretinal photocoagulation
时间窗: 54 weeks
To assess the efficacy of intravitreal pegaptanib sodium injections in inducing regression of high risk PDR (as determined by percentage of eyes without treatment failure) using standard panretinal photocoagulation (PRP) as the control arm. Treatment failure is defined as: * Development of increased NVD and/or NVE * NVD and/or NVE that is not regressed at least 50% compared to the baseline amount within 3 weeks * Development of significant vitreous hemorrhage that is sufficient in quantity to obscure visualization of the entire macula, optic disc, and the major temporal arcade vessels
次要结局
- Establish the efficacy of intravitreal pegaptanib injections in preventing the loss of best corrected visual acuity(54 weeks)
研究者
Victor H. Gonzalez, MD
Principal Investigator
Valley Retina Institute