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Dry Age-related Macular DegenerationPhase 2NCT03626636

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

A Phase 2 study testing Risuteganib in people with Dry Age-related Macular Degeneration, run by Allegro Ophthalmics, LLC at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and exploratory efficacy of 1.0mg of Luminate® in patients with Intermediate Non-Exudative Macular Degeneration Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Dry Age-related Macular Degeneration
What is being tested?
Risuteganib
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
7 sitesUnited States
Study dates
1 Aug 2017to 4 Apr 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Florida Eye Clinic

    Altamonte Springs, Florida, 32701

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Derek Kunimoto

    Gilbert, Arizona, 85014

  • Raj Maturi

    Indianapolis, Indiana, 46290

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Derek Kunimoto

    Phoenix, Arizona, 85014

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

Other trials in United States

About this study

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

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

Read the 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®.

Being tested
Risuteganib, Sham

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisuteganibDrug

    Also called ALG-1001, Luminate

    Subjects injected intravitreally with 1.0mg of Luminate®

  • ShamOther

    Sham injection

Study groups in NCT03626636
Study groupRoleWhat they receive
Active GroupActive comparatorTreatment Group 1: 25 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be injected intravitreally with 1.0mg of Luminate®
Receives: Drug: Risuteganib
Placebo GroupPlacebo comparatorTreatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BCVA

    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

    Measured: 8 month total study including crossover

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2018
  2. Study start1 Aug 2017
  3. Primary completion4 Apr 2019
  4. Study completion4 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03626636
Sponsor's protocol ID
Dry AMD
Status last verified
Jul 2020
First submitted
8 Aug 2018
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lad EM, Boyer DS, Heier JS, Kornfield JA, Kuppermann BD, Quiroz-Mercado H, Aubel JM, Karageozian LS, Karageozian HL, Sarayba MA, Karageozian VH, Kaiser PK. Color Vision and Microperimetry Changes in Nonexudative Age-Related Macular Degeneration After Risuteganib Treatment: Exploratory Endpoints in a Multicenter Phase 2a Double-Masked, Randomized, Sham-Controlled, Crossover Clinical Trial. Ophthalmic Surg Lasers Imaging Retina. 2022 Aug;53(8):430-438. doi: 10.3928/23258160-20220725-02. Epub 2022 Aug 1.

    PubMed 35951718

  • Boyer DS, Gonzalez VH, Kunimoto DY, Maturi RK, Roe RH, Singer MA, Xavier S, Kornfield JA, Kuppermann BD, Quiroz-Mercado H, Aubel J, Karageozian HL, Park JY, Karageozian VH, Karageozian L, Sarayba MA, Kaiser PK. Safety and Efficacy of Intravitreal Risuteganib for Non-Exudative AMD: A Multicenter, Phase 2a, Randomized, Clinical Trial. Ophthalmic Surg Lasers Imaging Retina. 2021 Jun;52(6):327-335. doi: 10.3928/23258160-20210528-05. Epub 2021 Jun 1.

    PubMed 34185587

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Risuteganib in people with Dry Age-related Macular Degeneration, run by Allegro Ophthalmics, LLC at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BCVA (time frame: 8 month total study including crossover). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03626636, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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