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Completed

NCT Number: NCT02435862

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

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.

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Key information

Conditions

Non-Proliferative Diabetic Retinopathy

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northern California Retina Vitreous Associates, Mountain View, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1.0mg Luminate®

Drug

2.0mg Luminate®

Drug

3.0mg Luminate®

Drug

Balanced Salt Solution for intravitreal injection in 0.10cc

Other

Primary outcomes

  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 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.

    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.

Sponsors and collaborators

Lead sponsor

Allegro Ophthalmics, LLC

Industry

Collaborators

  • Duke University
  • Trial Runners, LLC

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 6, 2015
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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