Uveitis, PosteriorPhase 1/2NCT02125266
Safety and Preliminary Efficacy Study of V404 PDS in Uveitis
A Phase 1/2 study testing V404 in people with Uveitis, Posterior and Uveitis, Intermediate, run by Forsight Vision4 at 5 sites in United States.
Trial summary
This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Posterior, Uveitis, Intermediate
- What is being tested?
- V404
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Confirmed diagnosis of active uveitis
- Sufficient lens/media clarity
- Meet best-corrected visual acuity criteria
- Willing and able to use contraception
Who cannot join
- Pregnant, breast feeding
- Uncontrolled glaucoma
- Intraocular surgery or periocular/intraocular injections within 6 weeks
- Periocular or intraocular steroid within 3 months
- Prior vitrectomy
- Prior corneal transplant
Show all 11Show fewer
- Prior fluocinolone implant
- Allergy or sensitivity to study drug
- Participation in other trial within 30 days
- Abnormal liver function
- History of positive serum tuberculosis test
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Arlington, Texas
Study site
Atlanta, Georgia
Study site
Cleveland, Ohio
Study site
Golden, Colorado
Study site
Omaha, Nebraska
About this study
Official title: A Prospective, Multi-Center, Randomized, Controlled Clinical Trial Designed to Evaluate the Safety and Preliminary Efficacy of V404 PDS in Chronic Noninfectious Uveitis
This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate
- Being tested
- V404
- Medical subject headings
- Uveitis, Posterior, Uveitis, Intermediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V404Drug
Also called Methotrexate
Sustained Release
| Study group | Role | What they receive |
|---|---|---|
| Low Dose V404 PDS | Experimental | Sustained intravitreal delivery of methotrexate (0.6 mg) Receives: Drug: V404 |
| High Dose V404 PDS | Experimental | Sustained intravitreal delivery of methotrexate (2.3 mg) Receives: Drug: V404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Measured: 6 months
Secondary outcomes (1)
Change in vitreous haze score
Measured: Baseline, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionMar 2015
Why it stopped: Study terminated due to unacceptable frequency of drug related adverse events
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forsight Vision4
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125266
- Sponsor's protocol ID
- V4041
- Status last verified
- Dec 2016
- First submitted
- 24 Apr 2014
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Controlled Clinical Trial Designed to Evaluate the Safety and Preliminary Efficacy of V404 PDS in Chronic Noninfectious Uveitis
- ClinicalTrials.gov ID
- NCT02125266
- Acronym / sponsor ID
- V4041
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to unacceptable frequency of drug related adverse events
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Forsight Vision4Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Apr 2014 (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.
This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose V404 PDS | Experimental | Drug: V404Sustained intravitreal delivery of methotrexate (0.6 mg) |
| High Dose V404 PDS | Experimental | Drug: V404Sustained intravitreal delivery of methotrexate (2.3 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Confirmed diagnosis of active uveitis
- Sufficient lens/media clarity
- Meet best-corrected visual acuity criteria
- Willing and able to use contraception
Key exclusion criteria (11 listed)
- Pregnant, breast feeding
- Uncontrolled glaucoma
- Intraocular surgery or periocular/intraocular injections within 6 weeks
- Periocular or intraocular steroid within 3 months
- Prior vitrectomy
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 |
|---|---|---|
| V404Also: MethotrexateSustained Release | Drug | High Dose V404 PDS, Low Dose V404 PDS |
Primary outcome
Frequency of adverse events
Time frame: 6 months
1 secondary outcome
Change in vitreous haze score
Time frame: Baseline, 6 Months
Results and safety
The study was stopped early (reason given: Study terminated due to unacceptable frequency of drug related adverse events). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing V404 in people with Uveitis, Posterior and Uveitis, Intermediate, run by Forsight Vision4 at 5 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 5 inclusion and 11 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 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Study terminated due to unacceptable frequency of drug related adverse events). 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?
Frequency of adverse events (time frame: 6 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 9 Dec 2016.