Age-Related Macular DegenerationPhase 4CLOVERNCT00680498
Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment
A Phase 4 study testing Ranibizumab and Ranibizumab plus Photodynamic therapy in people with Age-Related Macular Degeneration, run by Illinois Retina Associates at 1 site in United States.
Trial summary
This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group). 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 and Ranibizumab plus Photodynamic therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Oct 2009
- Phase
- Phase 4
- 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
- Presence of subfoveal CNV due to AMD, less than 9 disc areas in extent
- Vision 20/40 to 20/800 Snellen equivalent
- Age > 50 years
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
Who cannot join
- Intraocular surgery or injection within 30 days prior to enrollment in the study eye
- Intravitreal triamcinolone within the past 6 months in the study eye
- History of prior PDT treatment in the study eye
- History of argon laser treatment of subfoveal CNV in the study eye
- Other vision-limiting disease (e.g. advanced glaucoma, prior vascular occlusion, dense amblyopia) in the study eye
- Clinically significant intraocular inflammation in the study eye
Show all 13Show fewer
- No light perception in the fellow eye
- Anterior segment opacity preventing adequate visualization of fundus for FA or OCT
- Are currently participating in another clinical trial
- Women of childbearing potential not using adequate contraception, as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Use of any other investigational agent in the last 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Retina Associates
Oak Park, Illinois, 60304
About this study
This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group).
The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months.
The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Ranibizumab, Ranibizumab plus Photodynamic therapy
- Keywords
- Age-Related Macular Degeneration, Ranibizumab, Lucentis, Photodynamic Therapy, Verteporfin, Visudyne
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Ranibizumab 0.5 mg
Ranibizumab plus Photodynamic therapyDrug
Also called Lucentis, Visudyne
Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Ranibizumab |
| 2 | Active comparator | Not described Receives: Drug: Ranibizumab plus Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.
Measured: 1 year
Secondary outcomes (4)
Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.
Measured: 1 year
Determination of change in visual acuity from baseline.
Measured: 1 year
Determination of change in retinal thickness by optical coherence tomography (OCT).
Measured: 1 year
Determination of change in angiographic leakage from CNV.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startFeb 2007
- Primary completionJul 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illinois Retina Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Pauline T Merrill, MD, Principal investigator, Illinois Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680498
- Sponsor's protocol ID
- Clover 1
- Acronym
- CLOVER
- Status last verified
- Mar 2012
- First submitted
- 16 May 2008
- Last updated
- 28 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment
- ClinicalTrials.gov ID
- NCT00680498
- Acronym / sponsor ID
- CLOVER / Clover 1
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Age-Related Macular Degeneration, Ranibizumab, Lucentis, Photodynamic Therapy, Verteporfin, Visudyne
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Illinois Retina AssociatesUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Feb 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 20 May 2008 (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 is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group).
The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months.
The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ranibizumab |
| 2 | Active comparator | Drug: Ranibizumab plus Photodynamic therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of subfoveal CNV due to AMD, less than 9 disc areas in extent
- Vision 20/40 to 20/800 Snellen equivalent
- Age > 50 years
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
Key exclusion criteria (13 listed)
- Intraocular surgery or injection within 30 days prior to enrollment in the study eye
- Intravitreal triamcinolone within the past 6 months in the study eye
- History of prior PDT treatment in the study eye
- History of argon laser treatment of subfoveal CNV in the study eye
- Other vision-limiting disease (e.g. advanced glaucoma, prior vascular occlusion, dense amblyopia) in the study eye
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: LucentisRanibizumab 0.5 mg | Drug | 1 |
| Ranibizumab plus Photodynamic therapyAlso: Lucentis, VisudyneRanibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label) | Drug | 2 |
Primary outcome
To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.
Time frame: 1 year
4 secondary outcomes
Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.
Time frame: 1 year
Determination of change in visual acuity from baseline.
Time frame: 1 year
Determination of change in retinal thickness by optical coherence tomography (OCT).
Time frame: 1 year
Determination of change in angiographic leakage from CNV.
Time frame: 1 year
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 28 Mar 2012.
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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.
Pauline T Merrill, MD principal investigator
Illinois Retina Associates
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 Ranibizumab plus Photodynamic therapy in people with Age-Related Macular Degeneration, run by Illinois Retina Associates 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 4 inclusion and 13 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 28 Mar 2012. 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?
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?
To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity. (time frame: 1 year). 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 28 Mar 2012.