Age Related Macular DegenerationPhase 3FVF4193sNCT01255774
Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy
A Phase 3 study testing ranibizumab in people with Age Related Macular Degeneration, run by The New York Eye & Ear Infirmary at 1 site in United States.
Trial summary
The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels in aqueous and vitreous humor and active blood… Read more about this study
- Who is it for?
- Ages 51 to 90 years
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2012
- Phase
- Phase 3
- 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 51 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Subjects of either gender, Age > 50 years
- Best corrected visual acuity in the study eye between 20/40 and 20/320.
- Subfoveal choroidal neovascularization, secondary to age related macular degeneration.
- Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
- Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography
- Men must use barrier contraception or abstinence throughout the study.
- Ability to return for all study visits
Who cannot join
- Had ocular surgery within the past 60 days in the study eye.
- Had previous refractive eye surgery (RK, PRK, LASIK, ALK, etc.) within the past 3 months for the study eye.
- Has intraocular pressure ≥ 25 mmHg in the study eye.
- Has posterior uveitis in the study eye.
- Has ongoing infection in the study eye.
- Has retinal or optic nerve disease that could independently affect visual acuity including high axial myopia (>-8.00 D) and diabetic retinopathy in the study eye.
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- Has anterior segment and vitreous abnormalities that would preclude adequate observation of the fundus for photographs and fluorescein angiography in the study eye.
- Has received investigational therapy within 60 days prior to study entry.
- Has been previously enrolled in or previous treatment with MSI-1256F for injection.
- Has received prior approved treatment for subfoveal CNV within 60 days to study entry.
- Has clinically uncontrolled diabetes mellitus.
- Has other condition the investigator considers to be sound reasons for exclusion (e.g., lack of motivation, history of poor compliance, concomitant illnesses, personality disorder, mental condition, drug abuse, use of neuroleptics, physical or social condition predicting difficulty in long-term follow-up).
- Has an allergy to sodium fluorescein dye.
- Currently uses systemic or topical medications known to be toxic to the retina, lens, or optic nerve, such as deferoxamine, chloroquine/hydrochloroquine, tamoxifen, chlorpromazine, phenothiazines, steroids and ethambutol.
- 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 IUD, or contraceptive hormone implant or patch.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Eye and Ear Infirmary
New York, New York, 10003
Katy W Tai, CCRC, 212-979-4251, ktai@nyee.edu
About this study
Official title: Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy Measured Using The Optical Coherence Tomography (OCT) Scanning Laser Ophthalmoscope (SLO) And The Foresee Preferential Hyperacuity Perimeter
The rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of visual acuity in wet AMD, it is important to accurately measure anatomic response to treatments thereby enhancing the ability to understand patterns of response and predict the necessity for continued therapy.
- Conditions
- Age Related Macular Degeneration
- Being tested
- ranibizumab
- Keywords
- subfoveal CNV, Wet (Exudative) AMD, macular degeneration
- 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
An open-label, study of intravitreally administered ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Open Label use of Ranibizumab for wet age related macular degeneration Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central retinal thickness
To measure the mean change in central retinal thickness as measured by OCT/ SLO and Stratus OCT from Baseline to Month 12.
Measured: 12 months
Secondary outcomes (1)
change in central scotoma lesion size, density and distortion due to neovascularization
To measure the mean change in central scotoma lesion size and density as measured on OCT/ SLO microperimeter from Baseline to Month 12.
To measure the mean change in the scotoma size and distortion due to neovascularization as measured on the PHP from Baseline to Month 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJun 2007
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New York Eye & Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Richard B Rosen, MD, Principal investigator, New York Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255774
- Sponsor's protocol ID
- NYEE-07.14
- Acronym
- FVF4193s
- Status last verified
- Dec 2011
- First submitted
- 4 Dec 2010
- Last updated
- 5 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Retinal Thickness Changes And Scotoma Size Measured With Lucentis Therapy Measured Using The Optical Coherence Tomography (OCT) Scanning Laser Ophthalmoscope (SLO) And The Foresee Preferential Hyperacuity Perimeter
- ClinicalTrials.gov ID
- NCT01255774
- Acronym / sponsor ID
- FVF4193s / NYEE-07.14
- Conditions
- Age Related Macular Degeneration
- Keywords
- subfoveal CNV, Wet (Exudative) AMD, macular degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The New York Eye & Ear InfirmaryUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2007
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Dec 2010 (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 rationale for evaluating LucentisTM (a recombinant humanized anti-human Vascular Endothelial Growth Factor (VEGF) monoclonal antibody (Fab) in patients with neovascular (wet) Age related Macular Degeneration (AMD) is based on the strong correlation between VEGF levels in aqueous and vitreous humor and active blood vessel formation. LucentisTM has been shown to maintain or improve vision in wet AMD. Since the treatments do not halt the loss of visual acuity in wet AMD, it is important to accurately measure anatomic response to treatments thereby enhancing the ability to understand patterns of response and predict the necessity for continued therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: ranibizumabOpen Label use of Ranibizumab for wet age related macular degeneration |
Who may qualify
- Ages
- 51 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Subjects of either gender, Age > 50 years
- Best corrected visual acuity in the study eye between 20/40 and 20/320.
- Subfoveal choroidal neovascularization, secondary to age related macular degeneration.
- Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
Key exclusion criteria (16 listed)
- Had ocular surgery within the past 60 days in the study eye.
- Had previous refractive eye surgery (RK, PRK, LASIK, ALK, etc.) within the past 3 months for the study eye.
- Has intraocular pressure ≥ 25 mmHg in the study eye.
- Has posterior uveitis in the study eye.
- Has ongoing infection 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: LucentisAn open-label, study of intravitreally administered ranibizumab | Drug | Ranibizumab |
Primary outcome
Central retinal thickness
Time frame: 12 months
To measure the mean change in central retinal thickness as measured by OCT/ SLO and Stratus OCT from Baseline to Month 12.
1 secondary outcome
change in central scotoma lesion size, density and distortion due to neovascularization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
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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 B Rosen, MD principal investigator
New York Eye and Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ranibizumab in people with Age Related Macular Degeneration, run by The New York Eye & Ear Infirmary 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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 5 Dec 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katy W Tai, CCRC (212-979-4251, ktai@nyee.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central retinal thickness (time frame: 12 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 5 Dec 2011.