Venous Retinal Branch OcclusionPhase 1NCT01011374
Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
A Phase 1 study testing ranibizumab (Lucentis) in people with Venous Retinal Branch Occlusion and Central Retinal Vein Occlusion, run by Retina Associates of Cleveland, Inc at 1 site in United States.
Trial summary
This is a prospective, single-center, non-randomized clinical study on the impact of intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Retinal Branch Occlusion, Central Retinal Vein Occlusion, Retinal Vein Occlusion
- What is being tested?
- ranibizumab (Lucentis)
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- 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
- Evidence of central retinal vein occlusion, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or branch retinal vein occlusion, as documented on clinical exam
- Age 18 years or over
- Central macular edema on clinical exam as well as imaging with a central thickness of ≥ 250 microns
- Visual acuity ranging from 20/8000 to 20/40
- Media clarity and patient cooperation sufficient to allow adequate testing utilizing OCT and FA
- No previous treatment that might compromise or confound assessment of the study outcomes
- Ability to speak and read English
Who cannot join
- Acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements
- Concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise
- History of grid/focal laser in the study eye
- History of vitreal surgery
- Previous treatment with triamcinolone acetonide in either eye
- Previous use of bevacizumab, pegaptanib, or ranibizumab in either eye
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- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
- History of cerebrovascular accident within 1 year prior to Day 0
- Inability to comply with study or follow-up procedures
- Any cognitive defect as a result of mental disease, previous injury, or disease process that may interfere with interpretation of study results
- Visual acuity better than 20/40
- Pregnancy (positive pregnancy test) or lactation
- Inadequate contraception in premenopausal women
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Associates of Cleveland
Cleveland, Ohio, 44122
About this study
Official title: Impact of Lucentis on Psychological Morbidity in Patients With Macular Edema and Neovascularization Secondary to Retinal Vein Occlusion
This is a prospective, single-center, non-randomized clinical study on the impact of intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion.
- Conditions
- Venous Retinal Branch Occlusion, Central Retinal Vein Occlusion, Retinal Vein Occlusion, Depression
- Being tested
- ranibizumab (Lucentis)
- Keywords
- Retinal vein occlusion, Ranibizumab, Lucentis, Depression
- Medical subject headings
- Retinal Vein Occlusion, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab (Lucentis)Drug
Also called Lucentis
0.5 mg, administered intravitreally every 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks.
Measured: 24 weeks
Secondary outcomes (1)
Secondary outcome measures are change in macular edema measured by OCT and estimated by central retinal thickening and correlations between change in visual acuity, depression, and retinal findings such as neovascularization, rubeosis, and perfusion.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2012 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Retinal Branch OcclusionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Retina Associates of Cleveland, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Lawrence J Singerman, MD, Principal investigator, Retina Associates of Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011374
- Sponsor's protocol ID
- FVF4638s
- Status last verified
- Mar 2011
- First submitted
- 9 Nov 2009
- Last updated
- 18 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lucentis on Psychological Morbidity in Patients With Macular Edema and Neovascularization Secondary to Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT01011374
- Acronym / sponsor ID
- FVF4638s
- Conditions
- Venous Retinal Branch Occlusion, Central Retinal Vein Occlusion, Retinal Vein Occlusion, Depression
- Keywords
- Retinal vein occlusion, Ranibizumab, Lucentis, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Retina Associates of Cleveland, IncUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2009
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 11 Nov 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 is a prospective, single-center, non-randomized clinical study on the impact of intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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
- Evidence of central retinal vein occlusion, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or branch retinal vein occlusion, as documented on clinical exam
- Age 18 years or over
- Central macular edema on clinical exam as well as imaging with a central thickness of ≥ 250 microns
- Visual acuity ranging from 20/8000 to 20/40
Key exclusion criteria (13 listed)
- Acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements
- Concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise
- History of grid/focal laser in the study eye
- History of vitreal surgery
- Previous treatment with triamcinolone acetonide in either 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 |
|---|---|---|
| ranibizumab (Lucentis)Also: Lucentis0.5 mg, administered intravitreally every 4 weeks | Drug | – |
Primary outcome
The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks.
Time frame: 24 weeks
1 secondary outcome
Secondary outcome measures are change in macular edema measured by OCT and estimated by central retinal thickening and correlations between change in visual acuity, depression, and retinal findings such as neovascularization, rubeosis, and perfusion.
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
Lawrence J Singerman, MD principal investigator
Retina Associates of Cleveland
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 ranibizumab (Lucentis) in people with Venous Retinal Branch Occlusion and Central Retinal Vein Occlusion, run by Retina Associates of Cleveland, Inc 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 13 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 18 Mar 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 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?
Results are not available in the source record.
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?
The primary outcome measures are changes in the VFQ-25, GHQ-12, and PHQ-9 survey scores from baseline through 24 weeks. (time frame: 24 weeks). 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 18 Mar 2011.