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

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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

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 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

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




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



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.

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


Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT02348918     History of Changes
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:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents