Macular DegenerationPhase 2NCT00032396
A Study to Evaluate Retisert in the Treatment of Patients With the "Wet" Form of Age-Related Macular Degeneration
A Phase 2 study testing Retisert Implant in people with Macular Degeneration, run by Control Delivery Systems at 1 site in United States.
Trial summary
A study evaluating Retisert in patients with age-related macular degeneration Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Retisert Implant
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to not given
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Trial locations and contacts
1 site in 1 country.
United States1 site
Control Delivery Systems, Inc.
Watertown, Massachusetts, 02472
About this study
A study evaluating Retisert in patients with age-related macular degeneration
- Conditions
- Macular Degeneration
- Being tested
- Retisert Implant
- Keywords
- AMD, ARMD, Age-Related Macular Degeneration, Subfoveal Choroidal Neovascularization, CNV
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retisert ImplantDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2002 (estimated)
- Study startNov 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Control Delivery Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032396
- Sponsor's protocol ID
- CDS FL-004
- Status last verified
- Dec 2002
- First submitted
- 20 Mar 2002
- Last updated
- 29 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Retisert in the Treatment of Patients With the "Wet" Form of Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00032396
- Acronym / sponsor ID
- CDS FL-004
- Conditions
- Macular Degeneration
- Keywords
- AMD, ARMD, Age-Related Macular Degeneration, Subfoveal Choroidal Neovascularization, CNV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Control Delivery SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Nov 2001
- First posted
- 22 Mar 2002 (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 study evaluating Retisert in patients with age-related macular degeneration
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Retisert Implant | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2006.
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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 2 study testing Retisert Implant in people with Macular Degeneration, run by Control Delivery Systems at 1 site 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?
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: status not confirmed, as of the sponsor's last update on 29 May 2006. 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 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 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?
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.
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 29 May 2006.