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A Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate® (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration

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ClinicalTrials.gov Identifier: NCT03626636
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE August 13, 2018
Last Update Posted Date July 8, 2020
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date April 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2019)
Change in BCVA [ Time Frame: 8 month total study including crossover ]
1. Percentage of population with ≥ 8 letters (1 ½ lines) BCVA gain in the Luminate group (Treatment group 1 that received 2 doses of Luminate) from baseline to study week 28 vs the Sham control group from baseline to study week 12
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2018)
Improvement in BCVA [ Time Frame: 1 year total study including crossover ]
Percentage of population with ≥ 5 letters BCVA gain from baseline to study week 28 in 1.0mg Luminate vs baseline to study week 12 for Sham control
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate® (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration
Official Title  ICMJE A Randomized Controlled, Double-Masked, Crossover Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of 1.0 Mg Luminate® (Alg-1001) As A Treatment For Non-Exudative Macular Degeneration
Brief Summary To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration
Detailed Description

Approximately 40 eligible subjects who have been diagnosed with intermediate Non-Exudative AMD, that require treatment will be enrolled and randomized (1.7:1) to one of 2 treatment groups:

Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected intravitreally with 1.0mg of Luminate® Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection

At the 16-week visit, the study will be unmasked to the sponsor and injecting investigator (observing investigators will remain masked). Subjects in the treatment group will receive a 2nd dose of Luminate®. Subjects in the control group will be offered the opportunity to crossover to treatment with a single dose of Luminate®.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Age-related Macular Degeneration
Intervention  ICMJE
  • Drug: Risuteganib
    Subjects injected intravitreally with 1.0mg of Luminate®
    Other Name: ALG-1001, Luminate
  • Other: Sham
    Sham injection
Study Arms  ICMJE
  • Active Comparator: Active Group
    Treatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected intravitreally with 1.0mg of Luminate®
    Intervention: Drug: Risuteganib
  • Placebo Comparator: Placebo Group
    Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection
    Intervention: Other: Sham
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: July 7, 2020)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2018)
40
Actual Study Completion Date  ICMJE April 4, 2019
Actual Primary Completion Date April 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients, 50 to 85 years of age at screening visit
  • Subject has signed the Informed Consent form
  • Subjects with Non-Exudative AMD having ETDRS BCVA between 33 and 72 letters read (equivalent to 20/40 - 20/200 on Snellen Chart) with the level of vision caused by the non-exudative AMD and no other factor/s
  • Subjects with symptomatic decrease in visual acuity in the last 12 months
  • Subjects with combination of areas of RPE disturbances (hyper or hypopigmentation) and/or > 1 large druse(n) (>125 microns) and/or multiple intermediate drusen (62-124 microns) in the macula as confirmed by the central reading center
  • Subjects with evidence of reasonably well-preserved areas of RPE by clinical examination and well-defined RPE and outer segment ellipsoid line by OCT examination in the central 1 mm of the macula as confirmed by the central reading center. More specifically, reasonable reasonably well- preserved central 1 mm of the macula means:
  • The RPE and outer retinal layers throughout the central 1 mm are intact
  • No signs of NVAMD such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material
  • No serous pigment epithelium detachments >100 microns in height

Exclusion Criteria:

  • Females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and/or not willing to maintain a reliable method of contraception during their participation in the study. Women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug.
  • Participation in an investigational drug or device study within 90 days of screening
  • Subjects with active exudative AMD in the fellow eye
  • Subjects who had anti-VEGF IVT in either eye in the past 90 days
  • Subjects with pigment epithelium detachments
  • Subjects with active exudative AMD
  • Subjects with any prior retina surgery
  • Subjects with pathology that could prevent observation and follow-up of macular structures and measurement of BCVA (i.e. advanced primary open angle glaucoma, any stage of normal tension glaucoma and corneal opacification)
  • Subjects that are likely to require cataract surgery in the opinion of the investigator within the study protocol period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (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 NCT03626636
Other Study ID Numbers  ICMJE Dry AMD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Allegro Ophthalmics, LLC
Study Sponsor  ICMJE Allegro Ophthalmics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Allegro Ophthalmics, LLC
Verification Date July 2020

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