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Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Luminate 1.0mg
Luminate 2.0mg
Luminate 3.0mg
Avastin
Luminate 0.5mg
Sponsored by
Allegro Ophthalmics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Associated Retina Consultants
  • Retina Vitreous Associates Medical Group
  • Northern California Retina Vitreous Associates
  • West Coast Retina
  • Orange County Retina Medical Group
  • New England Retina Associates
  • Florida Eye Clinic
  • Retina Specialty Institute
  • Center for Retina and Macular Disease
  • Wilmer Eye Institute at John Hopkins University
  • TLC Eye Group
  • Island Retina
  • Charlotte EENT Associates
  • Black Hills Regional Eye Institute
  • Austin Retina Associates
  • Retina Consultant of Houston
  • Spokane Eye Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Luminate 1.0mg group

Luminate 2.0mg group

Luminate 3.0mg group

Avastin® group

Avastin then Luminate 1.0 mg IVT + sham injection

Avastin then Luminate 0.5 mg IVT + sham injection

Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT

Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT

Avastin 1.25 mg + Sham IVT

Arm Description

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.

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.

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.

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.

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

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

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

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

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Outcomes

Primary Outcome Measures

Change in BCVA at Week 24
Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline

Secondary Outcome Measures

Full Information

First Posted
January 12, 2015
Last Updated
December 5, 2018
Sponsor
Allegro Ophthalmics, LLC
Collaborators
Trial Runners, LLC, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02348918
Brief Title
Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
May 16, 2017 (Actual)
Study Completion Date
June 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allegro Ophthalmics, LLC
Collaborators
Trial Runners, LLC, Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Luminate 1.0mg group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Luminate 2.0mg group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Luminate 3.0mg group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Avastin® group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Avastin then Luminate 1.0 mg IVT + sham injection
Arm Type
Active Comparator
Arm Description
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
Arm Title
Avastin then Luminate 0.5 mg IVT + sham injection
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT
Arm Type
Active Comparator
Arm Description
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
Arm Title
Avastin 1.25 mg + Sham IVT
Arm Type
Active Comparator
Arm Description
Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN
Intervention Type
Drug
Intervention Name(s)
Luminate 1.0mg
Other Intervention Name(s)
ALG-1001
Intervention Type
Drug
Intervention Name(s)
Luminate 2.0mg
Other Intervention Name(s)
ALG-1001
Intervention Type
Drug
Intervention Name(s)
Luminate 3.0mg
Other Intervention Name(s)
ALG-1001
Intervention Type
Drug
Intervention Name(s)
Avastin
Other Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
Luminate 0.5mg
Other Intervention Name(s)
ALG-1001
Primary Outcome Measure Information:
Title
Change in BCVA at Week 24
Description
Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline
Time Frame
Value of 24 Weeks minus baseline value

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicken Karageozian
Organizational Affiliation
Cheif Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
West Coast Retina
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
New England Retina Associates
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Florida Eye Clinic
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Wilmer Eye Institute at John Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
TLC Eye Group
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
Facility Name
Island Retina
City
Shirley
State/Province
New York
ZIP/Postal Code
11967
Country
United States
Facility Name
Charlotte EENT Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultant of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema

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