Macular EdemaNCT00726973
Pilot Study Reduced Fluence PDT /Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-related Macular Degeneration (AMD)
A study testing Ranibizumab and Ranibizumab monotherapy in people with Macular Edema, run by Lahey Clinic.
Trial summary
The purposes of this study is to determine if combination reduced fluence photodynamic therapy and Ranibizumab has: Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number of PDT treatments. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Ranibizumab and Ranibizumab monotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jul 2012
- Phase
- Interventional
- 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
- Male / Female > 50 years of age
- FA diagnosis of CNV lesions as described above
- Have a best corrected visual acuity letter score in the study eye between 72-24 letters (approximately 20/40 to 20/320) using ETDRS chart measured at 4 meters
- Central retinal (including lesion) thickness greater than or equal to 250 microns as measured by OCT
- Subretinal hemorrhage making up less than 50% of total lesion size and sparing the fovea
- Sufficiently clear ocular media including the lens to allow photography of the retina
- Written informed consent has been obtained.
Who cannot join
- Dense subfoveal hemorrhage (>50% of the lesion)
- Tear or rip of the retina pigment epithelium, idiopathic parafoveal telangiectasis or serous pigment epithelial detachment without CNV
- Geographic atrophy involving the foveal center
- Subretinal fibrotic scar in the study eye greater than 25% of the lesion
- Presence of any condition in study eye other than AMD known to be associated with CNV
- History diabetic retinopathy or diabetic macular edema
Show all 14Show fewer
- Previous pars plana vitrectomy
- Previous photodynamic therapy in the study eye
- Previous photodynamic therapy in the fellow eye with resultant choroidal hypoperfusion
- Previous intravitreal anti-VEGF or steroid injection in the study eye
- Previous thermal subfoveal laser treatment in study eye
- Anticipated need for ocular surgery in the study eye during the 13 month study period
- Known allergy or sensitivity to the study medication(s) its components, diagnostic agents used during the study (Fluorescein, dilation drops) or other agents required for the study procedures (ie: povidone iodine)
- Porphyria or other porphyrin sensitivity
About this study
Official title: A Pilot Study With Reduced Fluence Photodynamic Therapy With Visudyne Ranibizumab VS. Ranibizumab Only to Treat Exudative AMD
The purposes of this study is to determine if combination reduced fluence photodynamic therapy and Ranibizumab has:
Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number of PDT treatments. The study will also collect information on the safety of combination therapy and single therapy.
Read the detailed description
This will be a 13 month prospective, blinded, randomized sham controled parallel safety study. There will be 2 treatment arms.
Arm 1 will receive reduced fluence PDT at baseline followed immediately by an intravitreal injection of Lucentis. Subjects in arm 1 will receive 2 additional injections of Ranibizumab (Lucentis) over the next 2 months. Starting at month 3, they will receive combination reduced fluence PDT and intravitreal Ranibizumab (Lucentis) if they develop recurrence of the subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness > 100 microns compared to the best prior thickness measure on OCT. Patients will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab (Lucentis) every 3 months thereafter. Group 1 patients are eligible for treatment with combination reduced fluence PDT and Ranibizumab (Lucentis) at any point at the 3 month time point or thereafter. After month 3, if patients were not eligible for combined therapy (<3 months since the last combination therapy) and have >2 lines of vision loss or > 100 microns of increased retinal thickness on OCT compared to most recent measure at their monthly visit, they would be eligible for an injection of Ranibizumab (Lucentis) as monotherapy. Thereafter, subjects will have combination therapy if retreatment criteria were met and it has been >3 months since the last PDT treatment.
Study arm 2 will receive 3 monthly intravitreal injections of Ranibizumab (Lucentis). Following month 2, they will be eligible for re-treatment with Ranibizumab (Lucentis) if retreatment criteria are met (same criteria as study arm 1). At intervals of no less than 3 months from the previous sham PDT, they will receive sham PDT if retreatment criteria are met.
- Conditions
- Macular Edema
- Being tested
- Ranibizumab, Ranibizumab monotherapy
- Keywords
- Macular edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Ranibizumab, and reduced fluence PDT or sham PDT and Ranibizumab. For 2 months injected intravitreal Ranibizumab will be given. At month 3 subjects will receive combination reduced fluence PDT and intravitreal Ranibizumab. If they develop recurrence of subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness >100 microns compared to best thickness measure of OCT, subjects will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab every 3 months thereafter.
Ranibizumab monotherapyDrug
Also called lucentis
3 monthly intravitreal injections of Ranibizumab monotherapy. After month 2 they are eligible for retreatment with Ranibizumab if retreatment criteria are met (same as arm 1) At intervals of no less than 3 months from the previous sham PDT they will receive sham PDT if retreatment criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Reduced fluence (3300mW/cm2-50% standard fluence) PDT + ranibizumab Receives: Drug: Ranibizumab |
| 2 | Active comparator | Ranibizumab monotherapy Receives: Drug: Ranibizumab monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy will be proportion of subjects with best corrected visual acuity improvement of 15 or more letters from baseline and wil visual acuity stabilization, less than 15 letter loss from baseline at 13 months
Measured: at conclusion of subject enrollment
Secondary outcomes (1)
Mean change in ETDRS from baseline, number of Ranibizumab treatments w/reduced fluence PDT, proportion of patients with 6 lines of vision loss
Measured: at conclusion of subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startDec 2006
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: Unable to recruit study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey L Marx, M.D., Principal investigator, Lahey Clinic Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726973
- Sponsor's protocol ID
- 2006-085
- Status last verified
- May 2012
- First submitted
- 30 Jul 2008
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study With Reduced Fluence Photodynamic Therapy With Visudyne Ranibizumab VS. Ranibizumab Only to Treat Exudative AMD
- ClinicalTrials.gov ID
- NCT00726973
- Acronym / sponsor ID
- 2006-085
- Conditions
- Macular Edema
- Keywords
- Macular edema
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 1 Aug 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.
The purposes of this study is to determine if combination reduced fluence photodynamic therapy and Ranibizumab has:
Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number of PDT treatments. The study will also collect information on the safety of combination therapy and single therapy.
Detailed description
This will be a 13 month prospective, blinded, randomized sham controled parallel safety study. There will be 2 treatment arms.
Arm 1 will receive reduced fluence PDT at baseline followed immediately by an intravitreal injection of Lucentis. Subjects in arm 1 will receive 2 additional injections of Ranibizumab (Lucentis) over the next 2 months. Starting at month 3, they will receive combination reduced fluence PDT and intravitreal Ranibizumab (Lucentis) if they develop recurrence of the subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness > 100 microns compared to the best prior thickness measure on OCT. Patients will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab (Lucentis) every 3 months thereafter. Group 1 patients are eligible for treatment with combination reduced fluence PDT and Ranibizumab (Lucentis) at any point at the 3 month time point or thereafter. After month 3, if patients were not eligible for combined therapy (<3 months since the last combination therapy) and have >2 lines of vision loss or > 100 microns of increased retinal thickness on OCT compared to most recent measure at their monthly visit, they would be eligible for an injection of Ranibizumab (Lucentis) as monotherapy. Thereafter, subjects will have combination therapy if retreatment criteria were met and it has been >3 months since the last PDT treatment.
Study arm 2 will receive 3 monthly intravitreal injections of Ranibizumab (Lucentis). Following month 2, they will be eligible for re-treatment with Ranibizumab (Lucentis) if retreatment criteria are met (same criteria as study arm 1). At intervals of no less than 3 months from the previous sham PDT, they will receive sham PDT if retreatment criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RanibizumabReduced fluence (3300mW/cm2-50% standard fluence) PDT + ranibizumab |
| 2 | Active comparator | Drug: Ranibizumab monotherapyRanibizumab monotherapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male / Female > 50 years of age
- FA diagnosis of CNV lesions as described above
- Have a best corrected visual acuity letter score in the study eye between 72-24 letters (approximately 20/40 to 20/320) using ETDRS chart measured at 4 meters
- Central retinal (including lesion) thickness greater than or equal to 250 microns as measured by OCT
- Subretinal hemorrhage making up less than 50% of total lesion size and sparing the fovea
Key exclusion criteria (14 listed)
- Dense subfoveal hemorrhage (>50% of the lesion)
- Tear or rip of the retina pigment epithelium, idiopathic parafoveal telangiectasis or serous pigment epithelial detachment without CNV
- Geographic atrophy involving the foveal center
- Subretinal fibrotic scar in the study eye greater than 25% of the lesion
- Presence of any condition in study eye other than AMD known to be associated with CNV
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, and reduced fluence PDT or sham PDT and Ranibizumab. For 2 months injected intravitreal Ranibizumab will be given. At month 3 subjects will receive combination reduced fluence PDT and intravitreal Ranibizumab. If they develop recurrence of subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness >100 microns compared to best thickness measure of OCT, subjects will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab every 3 months thereafter. | Drug | 1 |
| Ranibizumab monotherapyAlso: lucentis3 monthly intravitreal injections of Ranibizumab monotherapy. After month 2 they are eligible for retreatment with Ranibizumab if retreatment criteria are met (same as arm 1) At intervals of no less than 3 months from the previous sham PDT they will receive sham PDT if retreatment criteria are met. | Drug | 2 |
Primary outcome
Primary efficacy will be proportion of subjects with best corrected visual acuity improvement of 15 or more letters from baseline and wil visual acuity stabilization, less than 15 letter loss from baseline at 13 months
Time frame: at conclusion of subject enrollment
1 secondary outcome
Mean change in ETDRS from baseline, number of Ranibizumab treatments w/reduced fluence PDT, proportion of patients with 6 lines of vision loss
Time frame: at conclusion of subject enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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.
Jeffrey L Marx, M.D. principal investigator
Lahey Clinic Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Ranibizumab and Ranibizumab monotherapy in people with Macular Edema, run by Lahey Clinic.
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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 10 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary efficacy will be proportion of subjects with best corrected visual acuity improvement of 15 or more letters from baseline and wil visual acuity stabilization, less than 15 letter loss from baseline at 13 months (time frame: at conclusion of subject enrollment). 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 10 May 2012.