Choroidal NeovascularizationPhase 3NCT00429962
Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV
A Phase 3 study testing intravitreal ranibizumab and intravitreal ranibizumab & photodynamic therapy in people with Choroidal Neovascularization and Age-Related Macular Degeneration, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Choroidal Neovascularization, Age-Related Macular Degeneration
- What is being tested?
- intravitreal ranibizumab and intravitreal ranibizumab & photodynamic therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2006to Jun 2008
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 50 years, subfoveal CNV of any type secondary to age-related macular degeneration (AMD), no "macula-treatment for the last 30 days (e.g. with PDT, TA, Laser, Macugen®).
- the area of the CNV must occupy at least >50% of the lesion (total lesion size under 5400 microns in greatest linear dimension)
- Occult CNV:
- recent disease progression
- bleeding
- VA decreased the last three months >5 letters or 2 or more than two lines (Snellen)
- 10% increase of the lesion size the last three months
- Best corrected visual acuity score between 24-73 letters (20/40 to 20/320) (ETDRS 4 m)
Who cannot join
- Prior treatment with mit Laser, PDT, Macugen, TA
- Prior treatment with radiatio, vitrectomy, transpupillary thermotherapy
- History of surgical intervention in the study eye within two months preceding day 1
- concurrent use of systemic anti-VEGF agents
- previous treatment with or participation in a clinical trial involving anti-angiogenic drugs (Pegaptanib, ranibizumab, anecortave acetate of corticosteroids).
- Ocular disorders in the study eye that may confound interpretation of the study results, including retinal detachment or macular hole (Stage 3 or 4), active intraocular inflammation (grade trace or above) or persistent macular edema due to uveitis or other inflammatory diseases
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- Retinal pigment epithelium tear, vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
- History of idiopathic or autoimmune-associated uveitis in either eye, active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye
- Extracapsular extraction of cataract with phacoemulsification within two months preceding day 1, or a history of post-operative complications within the last 12 months preceding day 1 or a history of post-operative complications within the last 12 months preceding day 1 in the study eye (uveitis, cyclitis, iritis etc.)
- Glaucoma with IOP>25 mmHg despite therapy
- Aphakia or absence of the posterior capsule in the study eye
- Spherical equivalent >-8
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Phase IIIb Study Comparing Safety, Tolerability and Efficacy Between Lucentis® Administered in Conjunction With PDT With Visudyne® and Lucentis® in Patients With Subfoveal CNV Secondary to Age-Related Macular Degeneration
This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD
Read the detailed description
Intravitreal ranibizumab has shown to increase average vision in patients with subfoveal CNV secondary to AMD. However, the treatment does not provide benefit to all patients and the treatment regimen requires monthly intravitreal injections. Ranibizumab is an anti-VEGF-A monoclonal antibody fragment. Verteporfin photodynamic therapy acts through occluding newly formed vessels. The combination of these therapies acting through different modes of action bears the potential to provide a more convenient and less frequent therapy while maintaining/improving the increase in vision improvement observed with ranibizumab monotherapy. The strategic goal is to evaluate whether intravitreal ranibizumab in combination with verteporfin photodynamic therapy is an effective, safe and convenient treatment for patients with subfoveal CNV secondary to AMD and explore potential advantages of such treatment compared to ranibizumab monotherapy
- Being tested
- intravitreal ranibizumab, intravitreal ranibizumab & photodynamic therapy
- Keywords
- subfoveal choroidal neovascularization (CNV), age-related macular degeneration, ranibizumab monotherapy, combined verteporfin-therapy, Lucentis® (ranibizumab), Visudyne®, photodynamic therapy
- 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.
intravitreal ranibizumabDrug
Also called Lucentis
intraocular injection
intravitreal ranibizumab & photodynamic therapyDrug
Also called Visudyne
intraocular injection photodynamic treatment (LASER) after intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | intravitreal ranibizumab used in combination with verteporfin photodynamic therapy Receives: Drug: intravitreal ranibizumab & photodynamic therapy |
| B | Active comparator | intravitreal ranibizumab Receives: Drug: intravitreal ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
First injection with PDT
Measured: monthly
Secondary outcomes (1)
Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJul 2006
- Primary completionJun 2008
- Study completionJun 2008
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 University Hospital, Basel, SwitzerlandThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Ulrike Schneider, MD, Study director, University Eye Clinic Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429962
- Sponsor's protocol ID
- 081-PRC-2006-005
- Status last verified
- Apr 2009
- First submitted
- 31 Jan 2007
- Last updated
- 7 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Phase IIIb Study Comparing Safety, Tolerability and Efficacy Between Lucentis® Administered in Conjunction With PDT With Visudyne® and Lucentis® in Patients With Subfoveal CNV Secondary to Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00429962
- Acronym / sponsor ID
- 081-PRC-2006-005
- Keywords
- subfoveal choroidal neovascularization (CNV), age-related macular degeneration, ranibizumab monotherapy, combined verteporfin-therapy, Lucentis® (ranibizumab), Visudyne®, photodynamic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Feb 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.
This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD
Detailed description
Intravitreal ranibizumab has shown to increase average vision in patients with subfoveal CNV secondary to AMD. However, the treatment does not provide benefit to all patients and the treatment regimen requires monthly intravitreal injections. Ranibizumab is an anti-VEGF-A monoclonal antibody fragment. Verteporfin photodynamic therapy acts through occluding newly formed vessels. The combination of these therapies acting through different modes of action bears the potential to provide a more convenient and less frequent therapy while maintaining/improving the increase in vision improvement observed with ranibizumab monotherapy. The strategic goal is to evaluate whether intravitreal ranibizumab in combination with verteporfin photodynamic therapy is an effective, safe and convenient treatment for patients with subfoveal CNV secondary to AMD and explore potential advantages of such treatment compared to ranibizumab monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: intravitreal ranibizumab & photodynamic therapyintravitreal ranibizumab used in combination with verteporfin photodynamic therapy |
| B | Active comparator | Drug: intravitreal ranibizumabintravitreal ranibizumab |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients over 50 years, subfoveal CNV of any type secondary to age-related macular degeneration (AMD), no "macula-treatment for the last 30 days (e.g. with PDT, TA, Laser, Macugen®).
- Best corrected visual acuity score between 24-73 letters (20/40 to 20/320) (ETDRS 4 m)
Key exclusion criteria (12 listed)
- Prior treatment with mit Laser, PDT, Macugen, TA
- Prior treatment with radiatio, vitrectomy, transpupillary thermotherapy
- History of surgical intervention in the study eye within two months preceding day 1
- concurrent use of systemic anti-VEGF agents
- previous treatment with or participation in a clinical trial involving anti-angiogenic drugs (Pegaptanib, ranibizumab, anecortave acetate of corticosteroids).
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 |
|---|---|---|
| intravitreal ranibizumabAlso: Lucentisintraocular injection | Drug | B |
| intravitreal ranibizumab & photodynamic therapyAlso: Visudyneintraocular injection photodynamic treatment (LASER) after intravenous injection | Drug | A |
Primary outcome
First injection with PDT
Time frame: monthly
1 secondary outcome
Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections
Time frame: monthly
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 Apr 2009.
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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.
Ulrike Schneider, MD study director
University Eye Clinic Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intravitreal ranibizumab and intravitreal ranibizumab & photodynamic therapy in people with Choroidal Neovascularization and Age-Related Macular Degeneration, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 8 inclusion and 12 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 Apr 2009. 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 Switzerland. 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?
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?
First injection with PDT (time frame: monthly). 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 Apr 2009.