A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin® in the Treatment of Diabetic Macular Edema (DME)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 17
- 主要终点
- Change in BCVA at Week 24
研究概览
简要总结
A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema
详细描述
To evaluate the safety and efficacy of Luminate® (ALG-1001) as compared to Avastin® in patients with diabetic macular edema
- Stage 1: 120 eligible subjects with DME will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of Luminate intravitreal injection or Avastin intravitreal injection. Subjects will be followed monthly for 24 weeks (6 months).
Stage 2 (select sites): 75 eligible subjects with DME will be enrolled and randomized to one of 5 treatment groups at an allocation ratio of 1:1:1:1:1; i.e., one of 2 doses of Luminate intravitreal injection or Avastin intravitreal injection (0.5 mg and 1.0 mg). Subjects will be followed monthly for 20 weeks (5 months).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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, 18 years of age or older.
- •Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
- •Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.
- •Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.
- •In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.
- •Intra-Ocular Pressure (IOP) is under control (i.e., IOP
- •≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.
- •Willing and able to return for all study visits.
- •Able to meet the extensive post-op evaluation regimen.
- •Understands and signs the informed consent form.
排除标准
- •Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.
- •Uncontrolled hypertension defined as systolic >180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
- •Screening HgA1c blood test > 10.0
- •Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.
- •A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.
- •History of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye.
- •Epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center.
- •Previous pars plana vitrectomy in the study eye
- •Any intraocular surgery in the study eye within the last 90 days prior to study enrollment.
- •YAG laser treatment in the study eye in last 30 days prior to study enrollment.
- •High myopia in the study eye, with a spherical equivalent of >8.00D at screening
- •Other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye.
- •Chronic or recurrent uveitis.
- •Ongoing ocular infection or inflammation in either eye.
- •A history of cataract surgery complications/vitreous loss in the study eye.
- •Congenital eye malformations in the study eye.
- •A history of penetrating ocular trauma in the study eye.
- •Mentally handicapped.
- •Pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window.
- •Nursing female.
- •Currently participating in any other clinical research study.
- •Contraindication to the study medication.
研究组 & 干预措施
Avastin® group
Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.
干预措施: Avastin (Drug)
Luminate 1.0mg group
Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
干预措施: Luminate 1.0mg (Drug)
Luminate 2.0mg group
Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
干预措施: Luminate 2.0mg (Drug)
Luminate 3.0mg group
Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
干预措施: Luminate 3.0mg (Drug)
Avastin then Luminate 1.0 mg IVT + sham injection
Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT
干预措施: Luminate 1.0mg (Drug)
Avastin then Luminate 1.0 mg IVT + sham injection
Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT
干预措施: Avastin (Drug)
Avastin then Luminate 0.5 mg IVT + sham injection
Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT
干预措施: Avastin (Drug)
Avastin then Luminate 0.5 mg IVT + sham injection
Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT
干预措施: Luminate 0.5mg (Drug)
Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
干预措施: Luminate 1.0mg (Drug)
Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
干预措施: Avastin (Drug)
Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
干预措施: Avastin (Drug)
Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
干预措施: Luminate 0.5mg (Drug)
Avastin 1.25 mg + Sham IVT
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN
干预措施: Luminate 0.5mg (Drug)
结局指标
主要结局
Change in BCVA at Week 24
时间窗: Value of 24 Weeks minus baseline value
Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline
次要结局
未报告次要终点