Macular DegenerationPhase 3NCT00157976
Double-Masked Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Age-Related Macular Degeneration
A Phase 3 study testing Photrex (rostaporfin) in people with Macular Degeneration, run by Miravant Pharmaceuticals at 4 sites in 4 countries.
Trial summary
The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Photrex (rostaporfin)
- How many people
- 660 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Sep 2005to not given
- Phase
- Phase 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
- Patients with age greater than or equal to 50 years with at least one subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Czechia1 site, 1 recruiting
- Recruiting
Multiple Investigators
Brno-Bohunice, Olomouc, Praha
Poland1 site, 1 recruiting
- Recruiting
Multiple Investigators
Warsaw, Bydgoszcz, Lubin
About this study
Official title: A Phase III Randomized, Multicenter, Multinational, Double-Masked, Placebo-Controlled Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Classic and Occult Subfoveal Choroidal Neovascularization Associated With AMD
The purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).
- Conditions
- Macular Degeneration
- Being tested
- Photrex (rostaporfin)
- Keywords
- Macular Degeneration, AMD, Visual Acuity
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photrex (rostaporfin)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Secondary outcomes (1)
Angiographic changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2005
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 660 participants
Sponsor and investigators
- Lead sponsor
- Miravant Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wendy J. Snyder, PhD, Study director, Miravant Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157976
- Sponsor's protocol ID
- MRVT-920101-OPH005
- Status last verified
- Nov 2005
- First submitted
- 8 Sep 2005
- Last updated
- 1 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Multicenter, Multinational, Double-Masked, Placebo-Controlled Study of Photrex (Rostaporfin) Photodynamic Therapy in the Treatment of Classic and Occult Subfoveal Choroidal Neovascularization Associated With AMD
- ClinicalTrials.gov ID
- NCT00157976
- Acronym / sponsor ID
- MRVT-920101-OPH005
- Conditions
- Macular Degeneration
- Keywords
- Macular Degeneration, AMD, Visual Acuity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants
- Lead sponsor
- Miravant PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- First posted
- 12 Sep 2005 (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 purpose of this study is to confirm the efficacy and safety of rostaporfin (PHOTREX) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with age greater than or equal to 50 years with at least one subfoveal CNV membrane secondary to AMD that can be demonstrated by fluorescein angiography.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Photrex (rostaporfin) | Drug | – |
Primary outcome
Visual Acuity
1 secondary outcome
Angiographic changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2005.
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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.
Wendy J. Snyder, PhD study director
Miravant Pharmaceuticals
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Photrex (rostaporfin) in people with Macular Degeneration, run by Miravant Pharmaceuticals at 4 sites in 4 countries.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 1 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bulgaria, Czechia, Poland, Romania. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miravant Pharmaceuticals (1-800-685-2959, ctinfo@miravant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity. 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 1 Dec 2005.