Choroidal NeovascularizationSpectral OCTNCT01025063
Use of Spectral OCT in Combination Therapy
An observational study of Choroidal Neovascularization, run by Barnes Retina Institute.
Trial summary
This study will investigate the safety and efficacy of treatment of choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) with a combination of ranibizumab (Lucentis) and verteporfin PDT (Visudyne), as compared with ranibizumab monotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choroidal Neovascularization
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Dec 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Barnes Retina Institute clinic
Who may be able to join
- Ability to give informed consent
- Patients with visual acuity of 20/40-20/320 in the study eye
- Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size.
- Total area of lesion components other that CNV must be less than 50% of the total lesion size.
- The lesion must be < 5400microns in greatest linear dimension (GLD).
- Lesion size < 10 DA
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- Occult with no classic CNV lesions must have presumed recent disease progression:
- Blood associated with the lesion at baseline
- Loss of visual acuity in the previous 3 months: a: > 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
- > 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
Who cannot join
- Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 or more with evidence of posterior segment abnormalities consistent with pathologic myopia), or CNV secondary to causes other than AMD
- Geographic atrophy in the study eye
- Tear (rip) of the retinal pigment epithelium
- Presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
- Intraocular surgery within 6 weeks of enrollment
- Active or history of ocular inflammation or infection in the study eye within the last 30 days
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- Subretinal hemorrhage > 50% of the total lesion
- History of submacular surgery, or transpupillary thermotherapy in the study eye
- Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
- Patients with severe disciform scarring
- History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery within 60 days prior to screening
- History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening
- Inability to make study visits
- Advanced glaucoma, uncontrolled glaucoma in the study eye (defined as intraocular pressure, IOP ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
- Allergies to porphyrins or a known hypersensitivity to any component of Visudyne®
- Patients with porphyria
- Pregnancy or lactation
About this study
This study will investigate the safety and efficacy of treatment of choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) with a combination of ranibizumab (Lucentis) and verteporfin PDT (Visudyne), as compared with ranibizumab monotherapy.
- Conditions
- Choroidal Neovascularization
- Keywords
- Spectral OCT, Choroidal Neovascularization, Lucentis, Visudyne, PDT, anti-VEGF
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lucentis (PRN group) | Not described | |
| Lucentis (3 Injections over three months) | Not described | |
| PDT (Reduced Fluence) and Lucentis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
This pilot study observed anatomical measures which are currently not defined since the new technology is unclear in regards to what changes are seen at the level of the RPE and photoreceptors.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnes Retina Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Rhonda Weeks, Barnes Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025063
- Sponsor's protocol ID
- CBPD952AUS18T
- Acronym
- Spectral OCT
- Status last verified
- Oct 2017
- First submitted
- 2 Dec 2009
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Spectral OCT in Combination Therapy
- ClinicalTrials.gov ID
- NCT01025063
- Acronym / sponsor ID
- Spectral OCT / CBPD952AUS18T
- Conditions
- Choroidal Neovascularization
- Keywords
- Spectral OCT, Choroidal Neovascularization, Lucentis, Visudyne, PDT, anti-VEGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Barnes Retina InstituteUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Dec 2009 (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 study will investigate the safety and efficacy of treatment of choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) with a combination of ranibizumab (Lucentis) and verteporfin PDT (Visudyne), as compared with ranibizumab monotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lucentis (PRN group) | – | – |
| Lucentis (3 Injections over three months) | – | – |
| PDT (Reduced Fluence) and Lucentis | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Barnes Retina Institute clinic
Key inclusion criteria (10 listed)
- Ability to give informed consent
- Patients with visual acuity of 20/40-20/320 in the study eye
- Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size.
- Total area of lesion components other that CNV must be less than 50% of the total lesion size.
- The lesion must be < 5400microns in greatest linear dimension (GLD).
Key exclusion criteria (17 listed)
- Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 or more with evidence of posterior segment abnormalities consistent with pathologic myopia), or CNV secondary to causes other than AMD
- Geographic atrophy in the study eye
- Tear (rip) of the retinal pigment epithelium
- Presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
- Intraocular surgery within 6 weeks of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This pilot study observed anatomical measures which are currently not defined since the new technology is unclear in regards to what changes are seen at the level of the RPE and photoreceptors.
Time frame: 3 months
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 30 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Neovascularization, run by Barnes Retina Institute.
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 10 inclusion and 17 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 30 Oct 2017. 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 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?
This pilot study observed anatomical measures which are currently not defined since the new technology is unclear in regards to what changes are seen at the level of the RPE and photoreceptors. (time frame: 3 months). 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 30 Oct 2017.