Choroidal NeovascularizationPhase 2/3NCT00305630
Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)
A Phase 2/3 study testing Periocular injection of triamcinolone acetonide 40mg in people with Choroidal Neovascularization and Age-Related Macular Degeneration, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Choroidal Neovascularization, Age-Related Macular Degeneration
- What is being tested?
- Periocular injection of triamcinolone acetonide 40mg
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2002to Nov 2005
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active choroidal neovascularization
- Age related macular degeneration
- Visual acuity 20/20 to 20/400
Who cannot join
- Neovascular lesion >6500 microns is greatest linear diameter
- More than one prior photodynamic therapy treatment
- Receiving systemic corticosteroids
- Intraocular pressure > 21 mm Hg or glaucoma medication use
- History of glaucoma or history of ocular hypertension
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Univeristy School of Medicine
Baltimore, Maryland, 21287
Oregon Health Science Univeristy
Portland, Oregon, 97239
About this study
Official title: Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy
Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.
- Being tested
- Periocular injection of triamcinolone acetonide 40mg
- Keywords
- Corticosteroids, Triamcinolone, Photodynamic therapy, Choroidal neovascularization, Age-related macular degeneration
- Medical subject headings
- Choroidal Neovascularization, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periocular injection of triamcinolone acetonide 40mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
Secondary outcomes (1)
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startJul 2002
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Investigators
- Douglas A Jabs, MD, MBA, Study chair, Johns Hopkins UniversityNeil M Bressler, MD, Principal investigator, Johns Hopkins Univeristy School of MedicineDavid J Wilson, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305630
- Sponsor's protocol ID
- IND 64263
- Status last verified
- Mar 2006
- First submitted
- 20 Mar 2006
- Last updated
- 22 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy
- ClinicalTrials.gov ID
- NCT00305630
- Acronym / sponsor ID
- IND 64263
- Keywords
- Corticosteroids, Triamcinolone, Photodynamic therapy, Choroidal neovascularization, Age-related macular degeneration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- Jul 2002
- Study completion
- Nov 2005
- First posted
- 22 Mar 2006 (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.
Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active choroidal neovascularization
- Age related macular degeneration
- Visual acuity 20/20 to 20/400
Key exclusion criteria (5 listed)
- Neovascular lesion >6500 microns is greatest linear diameter
- More than one prior photodynamic therapy treatment
- Receiving systemic corticosteroids
- Intraocular pressure > 21 mm Hg or glaucoma medication use
- History of glaucoma or history of ocular hypertension
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 |
|---|---|---|
| Periocular injection of triamcinolone acetonide 40mg | Drug | – |
Primary outcome
Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
1 secondary outcome
Safety
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 22 Mar 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.
Douglas A Jabs, MD, MBA study chair
Johns Hopkins University
Neil M Bressler, MD principal investigator
Johns Hopkins Univeristy School of Medicine
David J Wilson, MD principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Periocular injection of triamcinolone acetonide 40mg in people with Choroidal Neovascularization and Age-Related Macular Degeneration, run by Johns Hopkins University at 2 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 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: finished, as of the sponsor's last update on 22 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.. 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 22 Mar 2006.