Coats' DiseasePhase 1/2FVF4140SNCT00470977
Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy
A Phase 1/2 study testing ranibizumab injection (0.5 mg) in people with Coats' Disease and Idiopathic Retinal Telangiectasia, run by Manhattan Eye, Ear & Throat Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of intravitreal injections of ranibizumab in the treatment of AMD variants and other choroidal neovascularization (CNV) related conditions (Coats' disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coats' Disease, Idiopathic Retinal Telangiectasia, Retinal Angiomatous Proliferation
- What is being tested?
- ranibizumab injection (0.5 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2007to Dec 2010
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Clinical diagnosis of the following conditions: Coats' disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis.
- Visual acuity of 20/40 to 20/320 in the study eye on the ETDRS visual acuity chart.
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy is initiated
- Participation in another simultaneous medical investigation or trial
- Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Patients who have undergone intraocular surgery within the last 2 months.
- Patient participating in any other investigational drug study.
Show all 21Show fewer
- Use of an investigational drug or treatment related or unrelated to the patient's condition within 30 days prior to receipt of study medication (verteporfin, pegaptanib, or other AMD therapy in the study eye)
- Patient treated with systemic anti-VEGF or pro-VEGF agents within 3 months before enrollment.
- Previous treatment (in either eye) with intravitreal or intravenously administered Avastin (bevacizumab).
- Inability to obtain photographs to document CNV (including difficulty with venous access).
- Patient with a known adverse reaction to fluorescein dye.
- Patient has a history of any medical condition which would preclude scheduled visits or completion of the study.
- Patient has had insertion of scleral buckle in the study eye
- Patient has received radiation treatment.
- Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless as a result of yttrium aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens implantation.
- Pregnancy (positive pregnancy test) or lactation.
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an intrauterine device (IUD), or contraceptive hormone implant or patch.
- History of glaucoma filtering surgery in the study eye.
- Concurrent use of more than two therapies for glaucoma.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure > 30 mm Hg despite treatment with anti-glaucoma medication)
- Inability to comply with study or follow-up procedure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lenox Hill Hospital/Manhattan Eye Ear and Throat Institute
New York, New York, 10065
Lenox Hill Hospital/Manhattan Eye, Ear & Throat Institute
New York, New York, 10065
About this study
Official title: Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy With Intravitreal Injection of Lucentis (Ranibizumab Injection)
The purpose of this study is to evaluate the safety and tolerability of intravitreal injections of ranibizumab in the treatment of AMD variants and other choroidal neovascularization (CNV) related conditions (Coats' disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis) using the incidence and severity of adverse events.
Limited forms of treatment are available that limit the loss of visual acuity. However, the patients may not have any substantial improvement in acuity or function. Therefore there remains a significant unmet need for therapeutic options managing the neovascularization and its consequences.
Read more
Lucentis (ranibizumab) injection will be considered as an attempt to control the growth of the abnormal vessels because of evidence suggesting that angiogenic factors, such as vascular endothelial growth factor (VEGF), play a role in the pathogenesis of neovascular non-AMD conditions.
The rationale for the study design is as follows:
A 0.5 mg dose of Lucentis (ranibizumab), a commercially available preparation that is Food and Drug Administration (FDA) approved and labeled for intravitreal injection use for neovascular (wet) age-related macular degeneration will be used.
In AMD variants and other CNV related conditions, vascular endothelial growth factor (VEGF) plays a role in the pathogenesis as in neovascular AMD.
Intravitreal injection of ranibizumab delivers maximal concentration of the antibody fragment to the vitreous cavity with minimal systemic exposure. The dosing schedule, based on considerations of the half-life and the clinical response in patients with neovascularization suggests that a 1-month interval is optimal.
- Conditions
- Coats' Disease, Idiopathic Retinal Telangiectasia, Retinal Angiomatous Proliferation, Polypoidal Choroidal Vasculopathy, Pseudoxanthoma Elasticum, Pathological Myopia
- Being tested
- ranibizumab injection (0.5 mg)
- Medical subject headings
- Retinal Telangiectasis, Polypoidal Choroidal Vasculopathy, Pseudoxanthoma Elasticum, Myopia, Degenerative, von Hippel-Lindau Disease, Vitelliform Macular Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab injection (0.5 mg)Drug
Also called Lucentis
ranibizumab 10mg mg/ml. , 0.3ml/vial, 0.05 ml./injection intravitreally for 3months then prn for the next 21 months.
| Study group | Role | What they receive |
|---|---|---|
| (Ranibizumab) Lucentis | Experimental | (Ranibizumab)Lucentis 0.5% Receives: Drug: ranibizumab injection (0.5 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions
Measured: 24 months
Secondary outcomes (3)
Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline
Measured: 24 months
Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline
Measured: 24 months
Number of additional injections required following the initial 3 injections
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coats' DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Eye, Ear & Throat Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Joan, Manhattan Eye, Ear & Throat Hospital
- Investigators
- Lawrence A. Yannuzzi, MD, Principal investigator, LuEsther T. Mertz Retinal Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470977
- Sponsor's protocol ID
- Protocol: FVF4140S
- Acronym
- FVF4140S
- Status last verified
- Oct 2012
- First submitted
- 4 May 2007
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Exudative and Vasogenic Chorioretinal Diseases Including Variants of AMD and Other CNV Related Maculopathy With Intravitreal Injection of Lucentis (Ranibizumab Injection)
- ClinicalTrials.gov ID
- NCT00470977
- Acronym / sponsor ID
- FVF4140S / Protocol: FVF4140S
- Conditions
- Coats' Disease, Idiopathic Retinal Telangiectasia, Retinal Angiomatous Proliferation, Polypoidal Choroidal Vasculopathy, Pseudoxanthoma Elasticum, Pathological Myopia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Manhattan Eye, Ear & Throat HospitalUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 May 2007 (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 evaluate the safety and tolerability of intravitreal injections of ranibizumab in the treatment of AMD variants and other choroidal neovascularization (CNV) related conditions (Coats' disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis) using the incidence and severity of adverse events.
Limited forms of treatment are available that limit the loss of visual acuity. However, the patients may not have any substantial improvement in acuity or function. Therefore there remains a significant unmet need for therapeutic options managing the neovascularization and its consequences.
Lucentis (ranibizumab) injection will be considered as an attempt to control the growth of the abnormal vessels because of evidence suggesting that angiogenic factors, such as vascular endothelial growth factor (VEGF), play a role in the pathogenesis of neovascular non-AMD conditions.
The rationale for the study design is as follows:
A 0.5 mg dose of Lucentis (ranibizumab), a commercially available preparation that is Food and Drug Administration (FDA) approved and labeled for intravitreal injection use for neovascular (wet) age-related macular degeneration will be used.
In AMD variants and other CNV related conditions, vascular endothelial growth factor (VEGF) plays a role in the pathogenesis as in neovascular AMD.
Intravitreal injection of ranibizumab delivers maximal concentration of the antibody fragment to the vitreous cavity with minimal systemic exposure. The dosing schedule, based on considerations of the half-life and the clinical response in patients with neovascularization suggests that a 1-month interval is optimal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (Ranibizumab) Lucentis | Experimental | Drug: ranibizumab injection (0.5 mg)(Ranibizumab)Lucentis 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Clinical diagnosis of the following conditions: Coats' disease, idiopathic perifoveal telangiectasia, retinal angiomatous proliferation, polypoidal vasculopathy, pseudoxanthoma elasticum, pathological myopia, multi-focal choroiditis, rubeosis iridis.
- Visual acuity of 20/40 to 20/320 in the study eye on the ETDRS visual acuity chart.
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Key exclusion criteria (21 listed)
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy is initiated
- Participation in another simultaneous medical investigation or trial
- Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Patients who have undergone intraocular surgery within the last 2 months.
- Patient participating in any other investigational drug 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 injection (0.5 mg)Also: Lucentisranibizumab 10mg mg/ml. , 0.3ml/vial, 0.05 ml./injection intravitreally for 3months then prn for the next 21 months. | Drug | (Ranibizumab) Lucentis |
Primary outcome
Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions
Time frame: 24 months
3 secondary outcomes
Mean change in central retinal thickness as measured by OCT at month 12 compared to baseline
Time frame: 24 months
Change in leakage area seen during fluorescein angiography at month 12 as compared with baseline
Time frame: 24 months
Number of additional injections required following the initial 3 injections
Time frame: 24 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 25 Oct 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.
Lawrence A. Yannuzzi, MD principal investigator
LuEsther T. Mertz Retinal Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ranibizumab injection (0.5 mg) in people with Coats' Disease and Idiopathic Retinal Telangiectasia, run by Manhattan Eye, Ear & Throat Hospital at 2 sites 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 6 inclusion and 21 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 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability of intravitreal injections of ranibizumab in the treatment of non-AMD variants and other CNV related conditions (time frame: 24 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 25 Oct 2012.