Diabetic RetinopathyPhase 2/3NCT00664183
A Safety and Efficacy Study of Vitreosolve® for Non-Proliferative Diabetic Retinopathy Subjects
A Phase 2/3 study testing Vitreosolve in people with Diabetic Retinopathy, run by Vitreoretinal Technologies, Inc. at 17 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Vitreosolve
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Mar 2008to Dec 2009
- Phase
- Phase 2/3
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a history of systemic diabetes (type I or II)
- Subject with a documented history of Non Proliferative Diabetic Retinopathy (NPDR)
- Subjects with no PVD at baseline exam in the study eye.
Who cannot join
- Subjects with Retinal pathology in the study eye other than (NPDR)
- Subjects with high myopia in the study eye
- Subjects who have monocular vision or contra lateral vision of 20/200 or worse BCVA in the non-study eye.
- Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
- Subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments in the study eye.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States10 sites
Study site
Asheville, North Carolina
Study site
Beverly Hills, California
Study site
Gainesville, Florida
Study site
Indianapolis, Indiana
Study site
Lakeland, Florida
Study site
McAllen, Texas
Study site
New Albany, Indiana
Study site
Phoenix, Arizona
Study site
Santa Ana, California
Study site
Silverdale, Washington
India7 sites
LVPEI
Bhubhneshwar
Sankara Nethralaya
Chennai
Aravind
Coimbatore
AIIMS
Delhi
LVPEI
Hyderabad
Aravind
Madurai
Aravind
Puducherry
About this study
Official title: A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.
- Conditions
- Diabetic Retinopathy
- Being tested
- Vitreosolve
- Keywords
- diabetic retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitreosolveDrug
Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Vitreosolve |
| 2 | Experimental | Not described Receives: Drug: Vitreosolve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound
Measured: 7 Months
Secondary outcomes (1)
Ultrasound, OCT, Safety
Measured: 7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009 (estimated)
Why it stopped: slow enrollment , interim analysis conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitreoretinal Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baruch Kupperman, MD, Principal investigator, University of California, IrvineNaresh Mandova, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664183
- Sponsor's protocol ID
- PVD-301
- Status last verified
- Oct 2009
- First submitted
- 18 Apr 2008
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Safety and Efficacy Study of Vitreosolve® for Ophthalmic Intravitreal Injection in Retinopathy Subjects
- ClinicalTrials.gov ID
- NCT00664183
- Acronym / sponsor ID
- PVD-301
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment , interim analysis conducted.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Vitreoretinal Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (estimated)
- First posted
- 22 Apr 2008 (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.
The purpose of this study is to determine the safety and efficacy of Vitreosolve in diabetic retinopathy patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vitreosolve |
| 2 | Experimental | Drug: Vitreosolve |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with a history of systemic diabetes (type I or II)
- Subject with a documented history of Non Proliferative Diabetic Retinopathy (NPDR)
- Subjects with no PVD at baseline exam in the study eye.
Key exclusion criteria (5 listed)
- Subjects with Retinal pathology in the study eye other than (NPDR)
- Subjects with high myopia in the study eye
- Subjects who have monocular vision or contra lateral vision of 20/200 or worse BCVA in the non-study eye.
- Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
- Subjects that have had either vitrectomy surgery, intravitreal injections, or laser treatments 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 |
|---|---|---|
| VitreosolveIntravitreal injection | Drug | 1, 2 |
Primary outcome
Ultrasound
Time frame: 7 Months
1 secondary outcome
Ultrasound, OCT, Safety
Time frame: 7 Months
Results and safety
The study was stopped early (reason given: slow enrollment , interim analysis conducted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2009.
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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.
Baruch Kupperman, MD principal investigator
University of California, Irvine
Naresh Mandova, MD principal investigator
University of Colorado, Denver
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitreosolve in people with Diabetic Retinopathy, run by Vitreoretinal Technologies, Inc. at 17 sites in 2 countries.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 20 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: slow enrollment , interim analysis conducted.). Results are not available in the source record.
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?
Ultrasound (time frame: 7 Months). 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 20 Oct 2009.