Age Related Macular DegenerationPhase 3EXCITENCT00275821
Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
A Phase 3 study testing Ranibizumab 0.3 mg - 3 times monthly, then quarterly, Ranibizumab 0.5 mg - 3 times monthly, then quarterly and Ranibizumab 0.3 mg monthly in people with Age Related Macular Degeneration, run by Novartis at 1 site in Switzerland.
Trial summary
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Ranibizumab 0.3 mg - 3 times monthly, then quarterly, Ranibizumab 0.5 mg - 3 times monthly, then quarterly and Ranibizumab 0.3 mg monthly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2005to Jan 2008
- Phase
- Phase 3
- 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
- Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
- Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
Who cannot join
- Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
- History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery.
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-masked, Active-controlled, Multi-center Study Comparing the Efficacy and Safety of Ranibizumab Administered as Two Dosing Regimens in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Ranibizumab 0.3 mg - 3 times monthly, then quarterly, Ranibizumab 0.5 mg - 3 times monthly, then quarterly, Ranibizumab 0.3 mg monthly
- Keywords
- Age-related macular degeneration, ranibizumab
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.3 mg - 3 times monthly, then quarterlyDrug
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.5 mg - 3 times monthly, then quarterlyDrug
Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
Ranibizumab 0.3 mg monthlyDrug
Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.3 mg - 3 times monthly, then quarterly | Experimental | Not described Receives: Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly |
| Ranibizumab 0.5 mg - 3 times monthly, then quarterly | Experimental | Not described Receives: Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly |
| Ranibizumab 0.3 mg monthly | Active comparator | Not described Receives: Drug: Ranibizumab 0.3 mg monthly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12
Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
Measured: Baseline to Month 12
Secondary outcomes (3)
Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12
Fluorescein angiography was conducted in conjunction with color fundus photography at screening and at Months 6 and 12. Investigators used digital fluorescein angiograms to determine presence or absence of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Measured: Baseline to Month 12
Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12
Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.
Measured: Baseline to Month 12
Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12
Optical Coherence Tomography (OCT) was performed on both eyes at screening and monthly from baseline through Month 12 prior to study drug administration. OCT images were evaluated at the central reading center (CRC) by trained graders and ophthalmologists experienced in clinical trials.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionJan 2008
- Study completionJan 2008
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 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Novartis - Including Sites in Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275821
- Sponsor's protocol ID
- CRFB002A2302
- Acronym
- EXCITE
- Status last verified
- Feb 2011
- First submitted
- 11 Jan 2006
- Last updated
- 16 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Active-controlled, Multi-center Study Comparing the Efficacy and Safety of Ranibizumab Administered as Two Dosing Regimens in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00275821
- Acronym / sponsor ID
- EXCITE / CRFB002A2302
- Conditions
- Age Related Macular Degeneration
- Keywords
- Age-related macular degeneration, ranibizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Jan 2006 (estimated)
- Results
- Posted 16 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.3 mg - 3 times monthly, then quarterly | Experimental | Drug: Ranibizumab 0.3 mg - 3 times monthly, then quarterly |
| Ranibizumab 0.5 mg - 3 times monthly, then quarterly | Experimental | Drug: Ranibizumab 0.5 mg - 3 times monthly, then quarterly |
| Ranibizumab 0.3 mg monthly | Active comparator | Drug: Ranibizumab 0.3 mg monthly |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
- Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
Key exclusion criteria (4 listed)
- Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
- History of submacular surgery or other surgical intervention for AMD in the study eye, glaucoma filtration surgery, corneal transplant surgery.
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline.
- Other protocol-defined inclusion/exclusion criteria applied to the study.
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 |
|---|---|---|
| Ranibizumab 0.3 mg - 3 times monthly, then quarterlySubjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms. | Drug | Ranibizumab 0.3 mg - 3 times monthly, then quarterly |
| Ranibizumab 0.5 mg - 3 times monthly, then quarterlySubjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms. | Drug | Ranibizumab 0.5 mg - 3 times monthly, then quarterly |
| Ranibizumab 0.3 mg monthlySubjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms. | Drug | Ranibizumab 0.3 mg monthly |
Primary outcome
Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12
Time frame: Baseline to Month 12
Visual acuity (VA) was assessed in both eyes at each study visit using best correction determined from protocol refraction. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.
3 secondary outcomes
Mean Change From Baseline in the Total Lesion Area of the Study Eye at Month 12
Time frame: Baseline to Month 12
Mean Change From Baseline in Retinal Thickness at the Central Point of the Study Eye at Month 12
Time frame: Baseline to Month 12
Mean Change From Baseline in Retinal Thickness at the Central Subfield of the Study Eye at Month 12
Time frame: Baseline to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2011.
- 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.
Novartis study chair
Novartis - Including Sites in Germany
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 Ranibizumab 0.3 mg - 3 times monthly, then quarterly, Ranibizumab 0.5 mg - 3 times monthly, then quarterly and Ranibizumab 0.3 mg monthly in people with Age Related Macular Degeneration, run by Novartis 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 2 inclusion and 4 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 16 Mar 2011. 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?
Yes. Results are posted in the registry (first posted 16 Mar 2011). 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 From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12 (time frame: Baseline to Month 12). 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 16 Mar 2011.