A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD (Posterior Vitreous Detachment) in Non-Proliferative Diabetic Retinopathy

NCT02435862 | Completed Phase 2 DMC

• 1 other identifier: PVD-202
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 12

Brief Summary

A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.

Conditions

Non-Proliferative Diabetic Retinopathy

Keywords

Vitreolysis of the Vitreous

Outcome Measures

Primary Outcomes (1)

• Observation of pharmacologic induction of PVD.

  The primary endpoint of this study is observation of pharmacologic induction of at least a stage 3 PVD, with PVD defined as a complete PVD to the equator except for vitreopapillary adhesion as seen on B-scan Ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center.

  90 days

Secondary Outcomes (1)

• The secondary endpoints of this study is the observation of a complete stage 4 PVD to the equator including vitreopapillary release as seen by B-scan ultrasound and confirmed by OCT where possible by study day 90 as determined by the reading center.

  90 days

Study Arms (4)

1.0mg Luminate®

EXPERIMENTAL

1.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)

Drug: 1.0mg Luminate®

2.0mg Luminate®

EXPERIMENTAL

2.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)

Drug: 2.0mg Luminate®

3.0mg Luminate®

EXPERIMENTAL

3.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)

Drug: 3.0mg Luminate®

Balanced Salt Solution 0.10cc

PLACEBO COMPARATOR

Balanced Salt Solution 0.10cc injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)

Other: Balanced Salt Solution for intravitreal injection in 0.10cc

Interventions

1.0mg Luminate® DRUG

1.0mg Luminate®

2.0mg Luminate® DRUG

2.0mg Luminate®

3.0mg Luminate® DRUG

3.0mg Luminate®

Balanced Salt Solution for intravitreal injection in 0.10cc OTHER

Balanced Salt Solution 0.10cc

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Proliferative Diabetic Retinopathy Subjects of any grade
• Subjects with either a) no PVD, b) stage 1 PVD or c) stage 2 PVD at baseline by b-scan in the study eye
• Subjects that are at least 45 years of age
• Subjects that are free of other significant retinal pathologies that could interfere with the measurements or conduct of this study
• Intraocular Pressure under control, IOP 30 mm or less
• Male or female subjects
• Signed Informed Consent -

You may not qualify if:

• No media opacities or abnormalities that would preclude observation of the retina or performance of any study related imaging tests
• History of prior vitrectomy in the study eye
• Subjects with epiretinal membranes, vitreomacular adhesion, vitreomacular traction, or macular holes in the study eye at baseline
• Subjects with proliferative DR, neovascular AMD, or retinal vascular occlusion in the study eye
• Subjects with clinically significant macular edema in the study eye
• Subjects with a history of focal/grid or pan-retinal laser photocoagulation in the study eye
• Subjects likely to need intraocular surgery, laser treatment, or non-study intravitreal injections in the study eye during the study period.
• Subjects with history of retinal detachment in the study eye
• High myopes with a spherical equivalent of \> -8.00 D spectacle correction in the study eye
• Subjects with systolic BP\> 180 at screening
• Subjects with HgA1c \>12.0 within 90 days preceding enrollment
• Subjects that have chronic or recurrent uveitis
• Subjects that have ongoing ocular infection or inflammation
• Subjects with uncontrolled glaucoma, ie IOP \> 25mm with or without IOP lowering agents
• Subjects that have contraindications to the study medication

Sponsors & Collaborators

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

Study Sites (12)

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

UCI Medical Center

Orange, California, 92868, United States

Location

New England Retina Associates

New London, Connecticut, 06320, United States

Location

Center for Retina and Macular Disease

Lakeland, Florida, 33805, United States

Location

Illinois Retina Center

Springfield, Illinois, 62704, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Retina Research Institute Of Texas

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

The Retina Group of Washington

Fairfax, Virginia, 22031, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Interventions

risuteganib; Intravitreal Injections

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Vicken Karageozian, MD

  Medical monitor

  STUDY DIRECTOR

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: May 1, 2015
• First Posted: May 6, 2015
• Study Start: February 1, 2015
• Primary Completion: August 10, 2017
• Study Completion: August 10, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

US (12)