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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02348918
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Trial Runners, LLC
Duke University
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC

Study Description
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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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Luminate 1.0mg Drug: Luminate 2.0mg Drug: Luminate 3.0mg Drug: Avastin Drug: Luminate 0.5mg Phase 2

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 13, 2014
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : June 13, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 Drug: Luminate 1.0mg
Other Name: ALG-1001
Active Comparator: 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.
 Drug: Luminate 2.0mg
Other Name: ALG-1001
Active Comparator: 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.
 Drug: Luminate 3.0mg
Other Name: ALG-1001
Active Comparator: 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.
 Drug: Avastin
Other Name: bevacizumab
Active Comparator: 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
 Drug: Luminate 1.0mg
Other Name: ALG-1001

Drug: Avastin
Other Name: bevacizumab
Active Comparator: 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
 Drug: Avastin
Other Name: bevacizumab

Drug: Luminate 0.5mg
Other Name: ALG-1001
Active Comparator: 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
 Drug: Luminate 1.0mg
Other Name: ALG-1001

Drug: Avastin
Other Name: bevacizumab
Active Comparator: 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
 Drug: Avastin
Other Name: bevacizumab

Drug: Luminate 0.5mg
Other Name: ALG-1001
Active Comparator: 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
 Drug: Luminate 0.5mg
Other Name: ALG-1001


Outcome Measures
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Primary Outcome Measures :
  1. Change in BCVA at Week 24 [ Time Frame: Value of 24 Weeks minus baseline value ]
    Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348918


Locations
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Sponsors and Collaborators
Allegro Ophthalmics, LLC
Trial Runners, LLC
Duke University
Investigators
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Study Director: Vicken Karageozian Cheif Medical Officer
  Study Documents (Full-Text)

Documents provided by Allegro Ophthalmics, LLC:
Study Protocol  [PDF] March 7, 2016
Statistical Analysis Plan  [PDF] March 17, 2017

More Information
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Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT02348918    
Other Study ID Numbers: DME 202B
First Posted: January 28, 2015    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors