Age-Related MaculopathyPhase 4NCT00473642
Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
A Phase 4 study testing Ranibizumab and Verteporfin in people with Age-Related Maculopathy and Choroidal Neovascularization, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Maculopathy, Choroidal Neovascularization
- What is being tested?
- Ranibizumab and Verteporfin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Apr 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or Female Patients > 50 years of age.
- Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.
- Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.
- If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye.
- Patients must be able and willing to provide written informed consent.
Who cannot join
- Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.
- Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.
- Choroidal neovascular membrane greater than 9 disc diameters in size.
- Previous posterior vitrectomy in the study eye.
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.
- Pregnant women or premenopausal women not using adequate contraception.
- History of allergy to fluorescein, Visudyne, Lucentis.
- Inability to comply with study or follow up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne® (Verteporfin) in Combination With Lucentis™ (Ranibizumab) for the Treatment of Age-Related Macular Degeneration
In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.
The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.
- Being tested
- Ranibizumab, Verteporfin
- Keywords
- Ranibizumab, Lucentis, Verteporfin, Visudyne, Photodynamic therapy
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
intravitreal administered ranibizumab 0.5 mg in 0.05 mL
VerteporfinDrug
Also called Visudyne
Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)
VerteporfinDrug
Also called Visudyne
Verteporfin with standard fluence photodynamic therapy (50 J/cm2)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard Fluence Photodynamic Therapy combined with ranibizumab Receives: Drug: Ranibizumab; Drug: Verteporfin |
| 2 | Experimental | Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab Receives: Drug: Ranibizumab; Drug: Verteporfin |
| 3 | Active comparator | Ranibizumab monotherapy Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months
Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
Measured: 12 months
Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol
Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
Measured: 12 months
Secondary outcomes (4)
Time to First Retreatment After Loading Doses
Measured: 12 months
Average Number of PDT Retreatments Over 12 Months
Measured: 12 months
Central Macular Thickness Reduction on OCT
Measured: 12 months
Average Number of Ranibizumab Retreatments Over 12 Months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-Related MaculopathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Scott J Westhouse, DO, Principal investigator, Oklahoma State University Medical CenterRaymond Townsend, MD, Principal investigator, Oklahoma State University Medical CenterJohn Saurino, DO, Principal investigator, Oklahoma State University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473642
- Sponsor's protocol ID
- 2007002
- Status last verified
- Nov 2020
- First submitted
- 14 May 2007
- Last updated
- 6 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne® (Verteporfin) in Combination With Lucentis™ (Ranibizumab) for the Treatment of Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00473642
- Acronym / sponsor ID
- 2007002
- Keywords
- Ranibizumab, Lucentis, Verteporfin, Visudyne, Photodynamic therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- May 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 15 May 2007 (estimated)
- Results
- Posted 8 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy.
The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ranibizumab, Drug: VerteporfinStandard Fluence Photodynamic Therapy combined with ranibizumab |
| 2 | Experimental | Drug: Ranibizumab, Drug: VerteporfinVerteporfin at 50% fluence photodynamic therapy combined with ranibizumab |
| 3 | Active comparator | Drug: RanibizumabRanibizumab monotherapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female Patients > 50 years of age.
- Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT.
- Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts.
- If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye.
- Patients must be able and willing to provide written informed consent.
Key exclusion criteria (8 listed)
- Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab.
- Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease.
- Choroidal neovascular membrane greater than 9 disc diameters in size.
- Previous posterior vitrectomy in the study eye.
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period.
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 |
|---|---|---|
| RanibizumabAlso: Lucentisintravitreal administered ranibizumab 0.5 mg in 0.05 mL | Drug | 1, 2, 3 |
| VerteporfinAlso: VisudyneVerteporfin with 50% fluence photodynamic therapy (25 J/cm2) | Drug | 2 |
| VerteporfinAlso: VisudyneVerteporfin with standard fluence photodynamic therapy (50 J/cm2) | Drug | 1 |
Primary outcome
Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months
Time frame: 12 months
Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol
Time frame: 12 months
Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss.
4 secondary outcomes
Time to First Retreatment After Loading Doses
Time frame: 12 months
Average Number of PDT Retreatments Over 12 Months
Time frame: 12 months
Central Macular Thickness Reduction on OCT
Time frame: 12 months
Average Number of Ranibizumab Retreatments Over 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Scott J Westhouse, DO principal investigator
Oklahoma State University Medical Center
Raymond Townsend, MD principal investigator
Oklahoma State University Medical Center
John Saurino, DO principal investigator
Oklahoma State University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab and Verteporfin in people with Age-Related Maculopathy and Choroidal Neovascularization, run by Oklahoma State University Center for Health Sciences 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?
The sponsor lists 5 inclusion and 8 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 6 Nov 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 6 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.