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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

Primary Purpose

Dry Age-related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Risuteganib

Sham

About this trial

This is an interventional treatment trial for Dry Age-related Macular Degeneration

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Derek Kunimoto
Derek Kunimoto
Retina Vitreous Associates Medical Group
Florida Eye Clinic
Raj Maturi
Valley Retina Institute
Medical Center Ophthalmology Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Group

Placebo Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03626636

First Posted

August 8, 2018

Last Updated

July 7, 2020

Sponsor

Allegro Ophthalmics, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03626636

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

April 4, 2019 (Actual)

Study Completion Date

April 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allegro Ophthalmics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Age-related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Treatment Group 2: 15 Non-Exudative AMD subjects with BCVA of 20/40 - 20/200 will be treated with a sham injection

Intervention Type

Drug

Intervention Name(s)

Risuteganib

Other Intervention Name(s)

ALG-1001, Luminate

Intervention Description

Subjects injected intravitreally with 1.0mg of Luminate®

Intervention Type

Other

Intervention Name(s)

Sham

Intervention Description

Sham injection

Primary Outcome Measure Information:

Title

Change in BCVA

Description

Time Frame

8 month total study including crossover

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Derek Kunimoto

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Facility Name

Derek Kunimoto

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Facility Name

Retina Vitreous Associates Medical Group

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Florida Eye Clinic

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32701

Country

United States

Facility Name

Raj Maturi

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

Valley Retina Institute

City

McAllen

State/Province

Texas

ZIP/Postal Code

78503

Country

United States

Facility Name

Medical Center Ophthalmology Associates

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78240

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35951718

Citation

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.

Results Reference

derived

PubMed Identifier

34185587

Citation

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.

Results Reference

derived

Learn more about this trial

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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