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

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ClinicalTrials.gov Identifier: NCT02435862
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
Duke University
Trial Runners, LLC
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC

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.

Condition or disease Intervention/treatment Phase
Non-Proliferative Diabetic Retinopathy Drug: 1.0mg Luminate® Drug: 2.0mg Luminate® Drug: 3.0mg Luminate® Other: Balanced Salt Solution for intravitreal injection in 0.10cc Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : August 10, 2017
Actual Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1.0mg Luminate®
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®
Experimental: 2.0mg Luminate®
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®
Experimental: 3.0mg Luminate®
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®
Placebo Comparator: Balanced Salt Solution 0.10cc
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



Primary Outcome Measures :
  1. Observation of pharmacologic induction of PVD. [ Time Frame: 90 days ]
    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 :
  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. [ Time Frame: 90 days ]
    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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435862


Locations
United States, California
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
UCI Medical Center
Orange, California, United States, 92868
United States, Connecticut
New England Retina Associates
New London, Connecticut, United States, 06320
United States, Florida
Center for Retina and Macular Disease
Lakeland, Florida, United States, 33805
United States, Illinois
Illinois Retina Center
Springfield, Illinois, United States, 62704
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
United States, Texas
Retina Research Institute Of Texas
Abilene, Texas, United States, 79606
Austin Retina Associates
Austin, Texas, United States, 78705
Valley Retina Institute
McAllen, Texas, United States, 78503
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240
United States, Virginia
The Retina Group of Washington
Fairfax, Virginia, United States, 22031
United States, Washington
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Allegro Ophthalmics, LLC
Duke University
Trial Runners, LLC
Investigators
Study Director: Vicken Karageozian, MD Medical monitor

Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT02435862     History of Changes
Other Study ID Numbers: PVD-202
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by Allegro Ophthalmics, LLC:
Vitreolysis of the Vitreous

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Vitreous Detachment
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pharmaceutical Solutions