Age Related Macular DegenerationPhase 2/3NCT00569569
Retaane® in Age-Related Macular Degeneration
A Phase 2/3 study testing juxtascleral depot injection of Retaane in people with Age Related Macular Degeneration, run by Rudolf Foundation Clinic.
Trial summary
The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. With visual loss threatening, there are only very few therapeutic options. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- juxtascleral depot injection of Retaane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Mar 2007
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rejection of intravitreal injections
- presence of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration
Who cannot join
- conditions precluding judgement of the fundus
About this study
The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. With visual loss threatening, there are only very few therapeutic options.
While these patients are neither suitable for laser therapy nor for photodynamic therapy with Verteporfin, antiangiogenic drugs applied intravitreally are now available.
Some patients however reject this therapeutic option because of potential complications such as endophthalmitis and the frequency of necessary injections. 20 patients who rejected intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a juxtascleral depot injection.
- Conditions
- Age Related Macular Degeneration
- Being tested
- juxtascleral depot injection of Retaane
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
juxtascleral depot injection of RetaaneDrug
juxtascleral depot injection of Retaane
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients treated with Retaane Receives: Drug: juxtascleral depot injection of Retaane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in VA
Measured: 6 months
Secondary outcomes (1)
Decrease in Macula Edema
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startFeb 2006
- Study completionMar 2007
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rudolf Foundation Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Binder, M.D., Study chair, no affiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569569
- Sponsor's protocol ID
- RFC012007
- Status last verified
- Dec 2007
- First submitted
- 5 Dec 2007
- Last updated
- 7 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retaane® in Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00569569
- Acronym / sponsor ID
- RFC012007
- Conditions
- Age Related Macular Degeneration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rudolf Foundation ClinicUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Dec 2007 (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 treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. With visual loss threatening, there are only very few therapeutic options.
While these patients are neither suitable for laser therapy nor for photodynamic therapy with Verteporfin, antiangiogenic drugs applied intravitreally are now available.
Some patients however reject this therapeutic option because of potential complications such as endophthalmitis and the frequency of necessary injections. 20 patients who rejected intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a juxtascleral depot injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: juxtascleral depot injection of RetaanePatients treated with Retaane |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- rejection of intravitreal injections
- presence of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration
Key exclusion criteria (1 listed)
- conditions precluding judgement of the fundus
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 |
|---|---|---|
| juxtascleral depot injection of Retaanejuxtascleral depot injection of Retaane | Drug | 1 |
Primary outcome
Increase in VA
Time frame: 6 months
1 secondary outcome
Decrease in Macula Edema
Time frame: 6 months
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 7 Dec 2007.
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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.
Susanne Binder, M.D. study chair
no affiliation
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing juxtascleral depot injection of Retaane in people with Age Related Macular Degeneration, run by Rudolf Foundation Clinic.
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 2 inclusion and 1 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 7 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Increase in VA (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 7 Dec 2007.