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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

Tracking Information
First Submitted Date  ICMJE January 12, 2015
First Posted Date  ICMJE January 28, 2015
Results First Submitted Date  ICMJE August 31, 2018
Results First Posted Date  ICMJE December 7, 2018
Last Update Posted Date December 7, 2018
Actual Study Start Date  ICMJE October 13, 2014
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
Change in OCT (Optical coherence tomagraphy) Central Subfield Thickness at Week 24 [ Time Frame: 24 Weeks ]
The primary efficacy outcome is OCT central subfield thickness at Week 24 as compared to baseline.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2015)
Change in BCVA at Week 24 [ Time Frame: 24 Weeks ]
Secondary efficacy outcome is BCVA changes at Week 24 as compared to baseline
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema
Official Title  ICMJE 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)
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Drug: Luminate 1.0mg
    Other Name: ALG-1001
  • Drug: Luminate 2.0mg
    Other Name: ALG-1001
  • Drug: Luminate 3.0mg
    Other Name: ALG-1001
  • Drug: Avastin
    Other Name: bevacizumab
  • Drug: Luminate 0.5mg
    Other Name: ALG-1001
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Luminate 1.0mg
  • 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.
    Intervention: Drug: Luminate 2.0mg
  • 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.
    Intervention: Drug: Luminate 3.0mg
  • 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.
    Intervention: Drug: Avastin
  • 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
    Interventions:
    • Drug: Luminate 1.0mg
    • Drug: Avastin
  • 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
    Interventions:
    • Drug: Avastin
    • Drug: Luminate 0.5mg
  • 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
    Interventions:
    • Drug: Luminate 1.0mg
    • Drug: Avastin
  • 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
    Interventions:
    • Drug: Avastin
    • Drug: Luminate 0.5mg
  • 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
    Intervention: Drug: Luminate 0.5mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
218
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2015)
150
Actual Study Completion Date  ICMJE June 13, 2017
Actual Primary Completion Date May 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02348918
Other Study ID Numbers  ICMJE DME 202B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allegro Ophthalmics, LLC
Study Sponsor  ICMJE Allegro Ophthalmics, LLC
Collaborators  ICMJE
  • Trial Runners, LLC
  • Duke University
Investigators  ICMJE
Study Director: Vicken Karageozian Cheif Medical Officer
PRS Account Allegro Ophthalmics, LLC
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP