Non-Proliferative Diabetic RetinopathyPhase 2NCT02435862
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 study testing 1.0mg Luminate®, 2.0mg Luminate® and 3.0mg Luminate® in people with Non-Proliferative Diabetic Retinopathy, run by Allegro Ophthalmics, LLC at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Non-Proliferative Diabetic Retinopathy
- What is being tested?
- 1.0mg Luminate®, 2.0mg Luminate® and 3.0mg Luminate®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 12 sitesUnited States
- Study dates
- 1 Feb 2015to 10 Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Retina Research Institute Of Texas
Abilene, Texas, 79606
Austin Retina Associates
Austin, Texas, 78705
The Retina Group of Washington
Fairfax, Virginia, 22031
Midwest Eye Institute
Indianapolis, Indiana, 46290
Center for Retina and Macular Disease
Lakeland, Florida, 33805
Valley Retina Institute
McAllen, Texas, 78503
Northern California Retina Vitreous Associates
Mountain View, California, 94040
New England Retina Associates
New London, Connecticut, 06320
UCI Medical Center
Orange, California, 92868
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Spokane Eye Clinical Research
Spokane, Washington, 99204
Illinois Retina Center
Springfield, Illinois, 62704
About this study
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
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
- Being tested
- 1.0mg Luminate®, 2.0mg Luminate®, 3.0mg Luminate®, Balanced Salt Solution for intravitreal injection in 0.10cc
- Keywords
- Vitreolysis of the Vitreous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.0mg Luminate®Drug
2.0mg Luminate®Drug
3.0mg Luminate®Drug
Balanced Salt Solution for intravitreal injection in 0.10ccOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Other: Balanced Salt Solution for intravitreal injection in 0.10cc |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start1 Feb 2015
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegro Ophthalmics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University, Trial Runners, LLC
- Responsible party
- Sponsor
- Investigators
- Vicken Karageozian, MD, Study director, Medical monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435862
- Sponsor's protocol ID
- PVD-202
- Status last verified
- Dec 2017
- First submitted
- 1 May 2015
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02435862
- Acronym / sponsor ID
- PVD-202
- Conditions
- Non-Proliferative Diabetic Retinopathy
- Keywords
- Vitreolysis of the Vitreous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Allegro Ophthalmics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Duke University, Trial Runners, LLC
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1.0mg Luminate® | Experimental | Drug: 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) |
| 2.0mg Luminate® | Experimental | Drug: 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) |
| 3.0mg Luminate® | Experimental | Drug: 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) |
| Balanced Salt Solution 0.10cc | Placebo comparator | Other: Balanced Salt Solution for intravitreal injection in 0.10ccBalanced Salt Solution 0.10cc injections at day 0, 30, and 60 (day 30 and 60 if a stage 4 PVD is not present) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicken Karageozian, MD study director
Medical monitor
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1.0mg Luminate®, 2.0mg Luminate® and 3.0mg Luminate® in people with Non-Proliferative Diabetic Retinopathy, run by Allegro Ophthalmics, LLC at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation of pharmacologic induction of PVD. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.