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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

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: NCT03626636
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC

Brief Summary:
To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Drug: Risuteganib Other: Sham Phase 2

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®.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : April 5, 2019
Estimated Study Completion Date : October 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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®
Drug: Risuteganib
Subjects injected intravitreally with 1.0mg of Luminate®
Other Name: ALG-1001, Luminate

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
Other: Sham
Sham injection




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03626636


Locations
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United States, Arizona
Derek Kunimoto
Gilbert, Arizona, United States, 85014
Derek Kunimoto
Phoenix, Arizona, United States, 85014
United States, California
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Florida
Florida Eye Clinic
Altamonte Springs, Florida, United States, 32701
United States, Indiana
Raj Maturi
Indianapolis, Indiana, United States, 46290
United States, Texas
Valley Retina Institute
McAllen, Texas, United States, 78503
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Allegro Ophthalmics, LLC
  Study Documents (Full-Text)

Documents provided by Allegro Ophthalmics, LLC:

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Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT03626636     History of Changes
Other Study ID Numbers: Dry AMD
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases