Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema
NCT ID: NCT02348918
Last Updated: 2018-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
218 participants
INTERVENTIONAL
2014-10-13
2017-06-13
Brief Summary
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Detailed Description
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\- 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Luminate 1.0mg
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.
Luminate 2.0mg
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.
Luminate 3.0mg
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.
Avastin
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
Luminate 1.0mg
Avastin
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
Avastin
Luminate 0.5mg
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
Luminate 1.0mg
Avastin
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
Avastin
Luminate 0.5mg
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
Luminate 0.5mg
Interventions
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Luminate 1.0mg
Luminate 2.0mg
Luminate 3.0mg
Avastin
Luminate 0.5mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Trial Runners, LLC
OTHER
Duke University
OTHER
Allegro Ophthalmics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Vicken Karageozian
Role: STUDY_DIRECTOR
Cheif Medical Officer
Locations
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Associated Retina Consultants
Phoenix, Arizona, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
West Coast Retina
San Francisco, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
New England Retina Associates
New London, Connecticut, United States
Florida Eye Clinic
Altamonte Springs, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Wilmer Eye Institute at John Hopkins University
Baltimore, Maryland, United States
TLC Eye Group
Jackson, Michigan, United States
Island Retina
Shirley, New York, United States
Charlotte EENT Associates
Charlotte, North Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultant of Houston
Houston, Texas, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DME 202B
Identifier Type: -
Identifier Source: org_study_id