Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema

NCT02348918 | Completed Phase 2 Results DMC

• 1 other identifier: DME 202B
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 17

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

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change in BCVA at Week 24

  Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline

  Value of 24 Weeks minus baseline value

Study Arms (9)

Luminate 1.0mg group

ACTIVE COMPARATOR

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.

Drug: Luminate 1.0mg

Luminate 2.0mg group

ACTIVE COMPARATOR

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.

Drug: Luminate 2.0mg

Luminate 3.0mg group

ACTIVE COMPARATOR

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.

Drug: Luminate 3.0mg

Avastin® group

ACTIVE COMPARATOR

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.

Drug: Avastin

Avastin then Luminate 1.0 mg IVT + sham injection

ACTIVE COMPARATOR

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

Drug: Luminate 1.0mg; Drug: Avastin

Avastin then Luminate 0.5 mg IVT + sham injection

ACTIVE COMPARATOR

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

Drug: Avastin; Drug: Luminate 0.5mg

Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT

ACTIVE COMPARATOR

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

Drug: Luminate 1.0mg; Drug: Avastin

Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT

ACTIVE COMPARATOR

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

Drug: Avastin; Drug: Luminate 0.5mg

Avastin 1.25 mg + Sham IVT

ACTIVE COMPARATOR

Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Drug: Luminate 0.5mg

Interventions

Luminate 1.0mg DRUG

Also known as: ALG-1001

Avastin then Luminate 1.0 mg IVT + sham injection; Luminate 1.0mg group; Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT

Luminate 2.0mg DRUG

Also known as: ALG-1001

Luminate 2.0mg group

Luminate 3.0mg DRUG

Also known as: ALG-1001

Luminate 3.0mg group

Avastin DRUG

Also known as: bevacizumab

Avastin then Luminate 0.5 mg IVT + sham injection; Avastin then Luminate 1.0 mg IVT + sham injection; Avastin® group; Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT; Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT

Luminate 0.5mg DRUG

Also known as: ALG-1001

Avastin 1.25 mg + Sham IVT; Avastin then Luminate 0.5 mg IVT + sham injection; Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allegro Ophthalmics, LLC: lead
• Trial Runners, LLC: collaborator
• Duke University: collaborator

Study Sites (17)

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

West Coast Retina

San Francisco, California, 94109, United States

Location

Orange County Retina Medical Group

Santa Ana, California, 92705, United States

Location

New England Retina Associates

New London, Connecticut, 06320, United States

Location

Florida Eye Clinic

Altamonte Springs, Florida, 32701, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Wilmer Eye Institute at John Hopkins University

Baltimore, Maryland, 21205, United States

Location

TLC Eye Group

Jackson, Michigan, 49202, United States

Location

Island Retina

Shirley, New York, 11967, United States

Location

Charlotte EENT Associates

Charlotte, North Carolina, 28210, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultant of Houston

Houston, Texas, 77098, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Interventions

risuteganib; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Allegro Ophthalmics, LLC

info@allegroeye.com

949-940-8130

Study Officials

• Vicken Karageozian

  Cheif Medical Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: January 28, 2015
• Study Start: October 13, 2014
• Primary Completion: May 16, 2017
• Study Completion: June 13, 2017
• Last Updated: December 7, 2018
• Results First Posted: December 7, 2018

Record last verified: 2018-12

Locations

US (17)