Age-Related Macular DegenerationPhase 1NCT01186432
Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)
A Phase 1 study testing PDS 1.0 in people with Age-Related Macular Degeneration, run by Forsight Vision4 at 1 site in Latvia.
Trial summary
This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with neovascular AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- PDS 1.0
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLatvia
- Study dates
- Aug 2010to Apr 2014
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated
- Retinal thickness due to edema of at least 300um in the study eye
- Best corrected visual acuity of 20/40 or worse in the study eye
- Best corrected visual acuity of 20/40 or better in the fellow eye
Who cannot join
- Evidence of scarring CNV (e.g. geographic atrophy) in the study eye
- Fibrosis >75% of lesion area in the study eye
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with neovascular AMD.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- PDS 1.0
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDS 1.0Drug
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | ranibizumab sustained delivery implant Receives: Drug: PDS 1.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retinal thickness measured by Optical Coherence Tomography
Measured: Monthly
Secondary outcomes (1)
Change in Best Corrected Visual Acuity
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01186432
- Sponsor's protocol ID
- FSV4 FH-1.2
- Status last verified
- Mar 2015
- First submitted
- 19 Aug 2010
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT01186432
- Acronym / sponsor ID
- FSV4 FH-1.2
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Forsight Vision4Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Aug 2010 (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 will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with neovascular AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: PDS 1.0ranibizumab sustained delivery implant |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated
- Retinal thickness due to edema of at least 300um in the study eye
- Best corrected visual acuity of 20/40 or worse in the study eye
- Best corrected visual acuity of 20/40 or better in the fellow eye
Key exclusion criteria (2 listed)
- Evidence of scarring CNV (e.g. geographic atrophy) in the study eye
- Fibrosis >75% of lesion area 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 |
|---|---|---|
| PDS 1.0 | Drug | Active |
Primary outcome
Change in retinal thickness measured by Optical Coherence Tomography
Time frame: Monthly
1 secondary outcome
Change in Best Corrected Visual Acuity
Time frame: Monthly
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 5 Mar 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PDS 1.0 in people with Age-Related Macular Degeneration, run by Forsight Vision4 at 1 site in Latvia.
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 4 inclusion and 2 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. 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 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.
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?
Change in retinal thickness measured by Optical Coherence Tomography (time frame: Monthly). 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 5 Mar 2015.