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

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)

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

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Avastin; Drug: Luminate 1.0mg; Drug: Luminate 2.0mg; Drug: Luminate 3.0mg; Drug: Luminate 0.5mg

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 Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants
  • California
    • Beverly Hills, California, United States, 90211
      • Retina Vitreous Associates Medical Group
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates
    • San Francisco, California, United States, 94109
      • West Coast Retina
    • Santa Ana, California, United States, 92705
      • Orange County Retina Medical Group
  • Connecticut
    • New London, Connecticut, United States, 06320
      • New England Retina Associates
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Florida Eye Clinic
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Wilmer Eye Institute at John Hopkins University
  • Michigan
    • Jackson, Michigan, United States, 49202
      • TLC Eye Group
  • New York
    • Shirley, New York, United States, 11967
      • Island Retina
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte EENT Associates
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Houston, Texas, United States, 77098
      • Retina Consultant of Houston
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

9

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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: Avastin; Other Names: bevacizumab; Drug: Luminate 1.0mg; Other Names: ALG-1001
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 Names: bevacizumab; Drug: Luminate 0.5mg; Other Names: 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: Avastin; Other Names: bevacizumab; Drug: Luminate 1.0mg; Other Names: ALG-1001
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 Names: bevacizumab; Drug: Luminate 0.5mg; Other Names: 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 Names: ALG-1001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BCVA at Week 24	Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline	Value of 24 Weeks minus baseline value

Collaborators and Investigators

• Sponsor: Allegro Ophthalmics, LLC
• Collaborators: Duke University; Trial Runners, LLC
• Investigators: Study Director: Vicken Karageozian, Cheif Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2014
• Primary Completion (Actual): May 16, 2017
• Study Completion (Actual): June 13, 2017

Study Registration Dates

• First Submitted: January 12, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: DME 202B