search
Back to results

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

Primary Purpose

Non-Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
1.0mg Luminate®
2.0mg Luminate®
3.0mg Luminate®
Balanced Salt Solution for intravitreal injection in 0.10cc
Sponsored by
Allegro Ophthalmics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Proliferative Diabetic Retinopathy focused on measuring Vitreolysis of the Vitreous

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. No media opacities or abnormalities that would preclude observation of the retina or performance of any study related imaging tests
  2. History of prior vitrectomy in the study eye
  3. Subjects with epiretinal membranes, vitreomacular adhesion, vitreomacular traction, or macular holes in the study eye at baseline
  4. Subjects with proliferative DR, neovascular AMD, or retinal vascular occlusion in the study eye
  5. Subjects with clinically significant macular edema in the study eye
  6. Subjects with a history of focal/grid or pan-retinal laser photocoagulation in the study eye
  7. Subjects likely to need intraocular surgery, laser treatment, or non-study intravitreal injections in the study eye during the study period.
  8. Subjects with history of retinal detachment in the study eye
  9. High myopes with a spherical equivalent of > -8.00 D spectacle correction in the study eye
  10. Subjects with systolic BP> 180 at screening
  11. Subjects with HgA1c >12.0 within 90 days preceding enrollment
  12. Subjects that have chronic or recurrent uveitis
  13. Subjects that have ongoing ocular infection or inflammation
  14. Subjects with uncontrolled glaucoma, ie IOP > 25mm with or without IOP lowering agents
  15. Subjects that have contraindications to the study medication
  16. Subjects who are unable to meet the extensive post-op evaluation regimen
  17. Pregnant or nursing women
  18. Subjects with a history of penetrating ocular trauma in the study eye
  19. Subjects that are participating in another clinical research study

Sites / Locations

  • Northern California Retina Vitreous Associates
  • UCI Medical Center
  • New England Retina Associates
  • Center for Retina and Macular Disease
  • Illinois Retina Center
  • Midwest Eye Institute
  • Retina Research Institute Of Texas
  • Austin Retina Associates
  • Valley Retina Institute
  • Medical Center Ophthalmology Associates
  • The Retina Group of Washington
  • Spokane Eye Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1.0mg Luminate®

2.0mg Luminate®

3.0mg Luminate®

Balanced Salt Solution 0.10cc

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 1, 2015
Last Updated
December 13, 2017
Sponsor
Allegro Ophthalmics, LLC
Collaborators
Duke University, Trial Runners, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02435862
Brief Title
A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD (Posterior Vitreous Detachment) in Non-Proliferative Diabetic Retinopathy
Official Title
Protocol PVD-202: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD in Non-Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
August 10, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allegro Ophthalmics, LLC
Collaborators
Duke University, Trial Runners, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Proliferative Diabetic Retinopathy
Keywords
Vitreolysis of the Vitreous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.0mg Luminate®
Arm Type
Experimental
Arm Description
1.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
Arm Title
2.0mg Luminate®
Arm Type
Experimental
Arm Description
2.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
Arm Title
3.0mg Luminate®
Arm Type
Experimental
Arm Description
3.0mg Luminate® injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
Arm Title
Balanced Salt Solution 0.10cc
Arm Type
Placebo Comparator
Arm Description
Balanced Salt Solution 0.10cc injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present)
Intervention Type
Drug
Intervention Name(s)
1.0mg Luminate®
Intervention Type
Drug
Intervention Name(s)
2.0mg Luminate®
Intervention Type
Drug
Intervention Name(s)
3.0mg Luminate®
Intervention Type
Other
Intervention Name(s)
Balanced Salt Solution for intravitreal injection in 0.10cc
Primary Outcome Measure Information:
Title
Observation of pharmacologic induction of PVD.
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 - Exclusion Criteria: 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 Subjects who are unable to meet the extensive post-op evaluation regimen Pregnant or nursing women Subjects with a history of penetrating ocular trauma in the study eye Subjects that are participating in another clinical research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicken Karageozian, MD
Organizational Affiliation
Medical monitor
Official's Role
Study Director
Facility Information:
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
UCI Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
New England Retina Associates
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Illinois Retina Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Retina Research Institute Of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
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
Facility Name
The Retina Group of Washington
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs