A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Efficacy of 36% Resolvine Injection versus 9% Resolvine Injection
研究概览
简要总结
This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion.
详细描述
This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion. The investigators propose that intravitreal injection of Resolvine® 36% will: 1)Result in release of the vitreous adhesion to the macula in subjects with symptomatic vitreomacular attachment (VMA). 2)The Release of the VMA will create a measurable and favorable retinal change. 3) The release of vitreomacular traction may also result in visual acuity improvement within the short time frame of this study.
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
- 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
- •Male or female subjects, 18 years of age or older
- •Willing and able to return for all study visits
- •Willing and able to provide written informed consent
- •Have symptomatic VMA.
- •If both eyes are found to have Anatomic VMA the eye with lower visual acuity will be declared the study eye.
排除标准
- •Subjects with high myopia in the study eye (axial length greater than or equal to 26.0 millimeters by ultrasound or spherical equivalent at the spectacle plane greater than -8.0 diopters)
- •Subjects who have monocular vision or contralateral vision of 20/400 or worse BCVA in the non-study eye
- •Subjects with a history of retinal detachment or tear in the study eye
- •Subjects who have PVD in the study eye at Baseline (Grade III or greater PVD by B-scan)
- •Subjects with unstable IOP (i.e. > 30 mmHg in the past six months) or IOP of > 21 mm Hg at enrollment, under medical control. Subjects may be on topical medications to control their IOP but may not stop or start a prostaglandin type or epinephrine based drug during the study.
- •Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
- •Subjects with a history of ocular trauma of any type in the study eye
- •Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye per the investigator's judgment
- •Subjects that have undergone any previous vitrectomy (either anterior or pars plana vitrectomy) in the study eye
- •Subjects with a history of cataract surgery complications in the study eye
- •Subjects that have undergone previous photocoagulation of the retina in the study eye
- •Subjects with any evidence or history of either nonproliferative or proliferative diabetic retinopathy (NPDR) or (PDR) in the study eye
- •Subjects with an anticipated need for cataract extraction in the study eye within the next 6 months
- •Subjects with congenital eye malformations
- •Subjects with recurrent uveitis or history of uveitis in either eye
- •Subjects with ongoing ocular infection or inflammation in the study eye
- •Subjects who are pregnant or nursing. Subjects of child bearing ages will undergo pregnancy testing.
- •Subjects that are currently participating in any other investigational research study
- •Subjects who are too ill to be likely to complete the entire study
- •Subjects who have undergone major surgery within the last 6 months (systemic or ocular) or who are likely to require major surgery in the upcoming 6 months
- •Subjects who are uncontrolled diabetics (HbA1/C > 10%) with significant morphological pathology at the time of enrollment
- •Subjects with macular holes Stage 2 or greater as determined by OCT, B-scan ultrasound and clinical examination
- •Subjects with epiretinal membrane (ERM) at the area of attachment as determined by OCT
- •Subjects that have received other intravitreal injection therapy within thirty (30) days of treatment with Resolvine®
- •Subjects that have received more than one Jetrea injection in the study eye
研究组 & 干预措施
36% Resolvine
Patients in this arm will be given one dose of 36% Resolvine intravitreal injection, with the possibility of a second dose at Day 30
干预措施: 36% Resolvine Intravitreal Injection (Drug)
9% Resolvine
Patients in this arm will be given one dose of 9% Resolvine intravitreal injection, with the possibility of a second dose at Day 30
干预措施: 9% Resolvine Intravitreal Injection (Drug)
结局指标
主要结局
Efficacy of 36% Resolvine Injection versus 9% Resolvine Injection
时间窗: After all patients have completed the 6 month follow-up
The primary objective of this study is to evaluate the efficacy of an active arm treated with Resolvine® 36%, which may contain up to two 100-microliter intravitreal injections, in comparison to a control arm treated with Resolvine 9%, which may contain up to two 100-microliter injections, in subjects with VMA. Efficacy will be measured by the percent of patients whose VMA has released after treatment.
Safety of 36% Resolvine Injection versus 9% Resolvine Injection
时间窗: After all patients have completed the 6 month follow-up.
The primary objective of this study is to evaluate the safety of an active arm treated with Resolvine® 36%, which may contain up to two 100-microliter intravitreal injections, in comparison to a control arm treated with Resolvine 9%, which may contain up to two 100-microliter injections, in subjects with VMA. Cumulative adverse event rates for each arm will be evaluated.
次要结局
- Improved Eye Function(After all patients have completed the 6 month follow-up.)
- Inducement of PVD(After all patients have completed the 6 month follow-up)
研究者
Jeffrey S Heier
Sponsor-Investigator
Ophthalmic Consultants of Boston