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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 1, 2015
First Posted Date  ICMJE May 6, 2015
Last Update Posted Date December 15, 2017
Actual Study Start Date  ICMJE February 1, 2015
Actual Primary Completion Date August 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-Proliferative Diabetic Retinopathy
Intervention  ICMJE
  • Drug: 1.0mg Luminate®
  • Drug: 2.0mg Luminate®
  • Drug: 3.0mg Luminate®
  • Other: Balanced Salt Solution for intravitreal injection in 0.10cc
Study Arms  ICMJE
  • 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: 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)
    Intervention: Other: Balanced Salt Solution for intravitreal injection in 0.10cc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2017)
105
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2015)
100
Actual Study Completion Date  ICMJE August 10, 2017
Actual Primary Completion Date August 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02435862
Other Study ID Numbers  ICMJE PVD-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allegro Ophthalmics, LLC
Study Sponsor  ICMJE Allegro Ophthalmics, LLC
Collaborators  ICMJE
  • Duke University
  • Trial Runners, LLC
Investigators  ICMJE
Study Director: Vicken Karageozian, MD Medical monitor
PRS Account Allegro Ophthalmics, LLC
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP