Central Serous ChorioretinopathyPhase 1NCT00403325
Intravitreal Ranibizumab Treatment of Central Serous Chorioretinopathy
A Phase 1 study testing rhuFab V2 [ranibizumab] ( Lucentis ) in people with Central Serous Chorioretinopathy, run by Vitreous -Retina- Macula Consultants of New York at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of Lucentis for active Central Serous Chorioretinopathy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- rhuFab V2 [ranibizumab] ( Lucentis )
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to not given
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A history of persistent central serous chorioretinopathy present for at least 3 months Best-corrected visual acuity (BCVA) of 20/40 (73 letters on the ETDRS chart) to light perception as measured by ETDRS protocol refraction.
- No signs of choroidal neovascularization
- Documented subfoveal fluid by OCT
- Active leak associated with the subfoveal fluid
- The ability and willingness to provide written informed consent
Who cannot join
- Prior treatment with laser or PDT
- Have uncontrolled hypertension
- Have a history of thromboembolic events including stroke, transient ischemic attacks, and myocardial infarction
- Have use of or need for continued anticoagulation therapy, except aspirin 325 mg/day.
- Are receiving or require chronic concomitant therapy with systemic (> 5 mg) or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for 14 or more consecutive days at any time within 6 months prior to screening
- Previously vitrectomized eyes.
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- Had allergic reactions to fluorescein dye or lack of venous access.
- Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc.
- An anticipated need for ocular surgery during the duration of the trial.
- Within 1 month prior to screening, have had intra ocular surgeries (including cataract surgery) in the study eye.
- Intravitreal triamcinolone or bevacizumab in the previous 2 months
- Uncontrolled glaucoma (IOP > 24 mmHg) on greater than 3 medications.
- Within 1 month prior to screening had YAG laser capsulotomy in the study eye
- Have received any other systemic experimental drug within 12 weeks prior to enrollment.
- Rubeosis iridis or neovascular glaucoma
- Any untreated rhegmatogenous retinal detachment.
- A visual acuity of worse than 20/400 in the fellow eye.
- Unwilling or unable to follow or comply with all study related procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vitreous Retina Macula Consultants of New York, P.C.
New York, New York, 10022
About this study
Official title: Phase I Study of Intravitreally Administered Ranibizumab in Subjects With Unresolving CSC and Subfoveal Fluid.
The purpose of this study is to examine the effects of Lucentis for active Central Serous Chorioretinopathy.
Read the detailed description
This is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with unresolving CSC and subfoveal fluid. Patients will be evaluated at baseline with ophthalmic examination, fluorescein angiography, optical coherence tomography, and color photography. Subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered every 28 days (± 2 days) for 3 injections. Thereafter they are to be evaluated every month until month 12. Treatment will be administered to patients if there is presence of active leakage as determined by fluorescein angiography or persistence presence of sub retinal fluid upon OCT examination at that monthly visit.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- rhuFab V2 [ranibizumab] ( Lucentis )
- Keywords
- Central Serous Chorioretinopathy
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhuFab V2 [ranibizumab] ( Lucentis )Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC)
Secondary outcomes (5)
Mean change in VA compared to baseline at month 6 and month 12
Proportion of patients with 20/20 vision at month 6 and 12 as compared to baseline
Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Change in subretinal fluid (as measured by optical coherence tomography) from baseline at month 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Richard F. Spaide, M.D., Principal investigator, Vitreous Retina Macula Consultants of New York, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403325
- Sponsor's protocol ID
- FVF3850S
- Status last verified
- Oct 2008
- First submitted
- 22 Nov 2006
- Last updated
- 3 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Intravitreally Administered Ranibizumab in Subjects With Unresolving CSC and Subfoveal Fluid.
- ClinicalTrials.gov ID
- NCT00403325
- Acronym / sponsor ID
- FVF3850S
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Central Serous Chorioretinopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New YorkUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2006
- First posted
- 23 Nov 2006 (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 purpose of this study is to examine the effects of Lucentis for active Central Serous Chorioretinopathy.
Detailed description
This is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with unresolving CSC and subfoveal fluid. Patients will be evaluated at baseline with ophthalmic examination, fluorescein angiography, optical coherence tomography, and color photography. Subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered every 28 days (± 2 days) for 3 injections. Thereafter they are to be evaluated every month until month 12. Treatment will be administered to patients if there is presence of active leakage as determined by fluorescein angiography or persistence presence of sub retinal fluid upon OCT examination at that monthly visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- A history of persistent central serous chorioretinopathy present for at least 3 months Best-corrected visual acuity (BCVA) of 20/40 (73 letters on the ETDRS chart) to light perception as measured by ETDRS protocol refraction.
- No signs of choroidal neovascularization
- Documented subfoveal fluid by OCT
- Active leak associated with the subfoveal fluid
- The ability and willingness to provide written informed consent
Key exclusion criteria (18 listed)
- Prior treatment with laser or PDT
- Have uncontrolled hypertension
- Have a history of thromboembolic events including stroke, transient ischemic attacks, and myocardial infarction
- Have use of or need for continued anticoagulation therapy, except aspirin 325 mg/day.
- Are receiving or require chronic concomitant therapy with systemic (> 5 mg) or topical ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken daily for 14 or more consecutive days at any time within 6 months prior to screening
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 |
|---|---|---|
| rhuFab V2 [ranibizumab] ( Lucentis ) | Drug | – |
Primary outcome
To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC)
5 secondary outcomes
Mean change in VA compared to baseline at month 6 and month 12
Proportion of patients with 20/20 vision at month 6 and 12 as compared to baseline
Proportion of patients losing ≤ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Proportion of patients gaining ≥ 15 letters as measured by ETDRS visual refraction at 4 meters compared to baseline at month 6 and 12
Change in subretinal fluid (as measured by optical coherence tomography) from baseline at month 3, 6, 9 and 12
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 3 Nov 2008.
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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.
Richard F. Spaide, M.D. principal investigator
Vitreous Retina Macula Consultants of New York, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rhuFab V2 [ranibizumab] ( Lucentis ) in people with Central Serous Chorioretinopathy, run by Vitreous -Retina- Macula Consultants of New York 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 5 inclusion and 18 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 3 Nov 2008. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of chronic central serous retinopathy (CSC). 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 3 Nov 2008.