Retinal Vein OcclusionPhase 2PADDLENCT00831350
Posterior Vitreous Detachment (PVD) Assessment During Dual Retinal Vein Occlusion (RVO) Lucentis Evaluations
A Phase 2 study testing Ranibizumab in people with Retinal Vein Occlusion and Posterior Vitreous Detachment, run by Barnes Retina Institute at 1 site in United States.
Trial summary
This is a study of subjects with retinal vein occlusion (RVO) specifically looking at the difference in outcomes between patients with posterior vitreous detachment (PVD) and those without PVD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Vein Occlusion, Posterior Vitreous Detachment
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2012
- Phase
- Phase 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Subjects of either gender, Age > 18 years
- Best corrected visual acuity in the study eye between 20/40 and 2/200 inclusive.
- Retinal venous occlusive disease (BRVO or CRVO)
- Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography, scheimpflug photography and high resolution OCT
- Ability to return for all study visits
Who cannot join
- 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.
- Prior RVO in the study eye
- Duration of RVO greater than 6 months
- Laser photocoagulation for macular edema within 3 months of Day 0
- Patients prior eye treatment including anti-VEGF therapy (within 3 months) or, intravitreal corticosteroid therapy (within 6 months)
Show all 19Show fewer
- Prior vitreoretinal surgery.
- Had ocular surgery within the past 60 days 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).
- Neovascular glaucoma
- Concurrent use of systemic anti-VEGF agents
- Has active infection in the study eye.
- Inability to obtain photographs.
- Has received investigational therapy within 60 days prior to study entry.
- Patients with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Has other conditions 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 fluorescein sodium dye.
- Inability to comply with study or follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posterior Vitreous Detachment (PVD) Assessment During Dual RVO Lucentis Evaluations (PADDLE Study)
This is a study of subjects with retinal vein occlusion (RVO) specifically looking at the difference in outcomes between patients with posterior vitreous detachment (PVD) and those without PVD. Posterior vitreous detachment is a condition where the gel-like substance that occupies the space between the retina and the lens of the eye liquefies and separates from the retina. 20 subjects from Barnes Retina Institute will be enrolled in this study. Based on a pre-treatment ultrasound (a test utilizing high-frequency sound waves to look at the inside of the eye), high resolution OCT (a noninvasive procedure called optical coherence tomography to check the thickness of your retina) and clinical exam, subjects will be assigned to one of 2 groups at baseline: Group 1 will be those with PVD and Group 2 will be those without PVD. Then subjects will receive monthly intravitreal (inside the eye) injections of Ranibizumab.
Read the detailed description
Several retinovascular diseases have been shown to be VEGF dependent including retinal vein occlusion, wet age-related macular degeneration, and diabetic retinopathy. The role of the vitreous or composition of the vitreous cavity has been examined in diabetic retinopathy on many occasions in the past and clinically it has been felt that a posterior vitreous separation leads a quieting and involution of diabetic retinopathy, both proliferative as well as pre-proliferative retinopathy. This clinical observation has never had any basic science data to support it. However, it has recently been shown that in cat eyes with posterior vitreous separation the vitreous cavity has a much lower VEGF concentration than in cat eyes with an attached posterior vitreous. This may be due to the fact that flow of oxygen from the retinal vasculature is increased by PVD. Vitreous oxygen levels are inversely associated with vitreous VEGF levels. As oxygen tension increases, VEGF levels will decline. This suggests if higher amounts of VEGF are present in the eye without PVD perhaps a powerful anti-VEGF drug, such as ranibizumab, may be of greater benefit to treat VEGF dependent retinovascular disease. To try and answer this question clinically, we have suggested that an analysis of the vitreous status in treatment naive eyes with retinal vein occlusion beginning ranibizumab therapy be undertaken to see if eyes without a posterior vitreous separation would achieve greater improvement in vision and a return to more normal retinal physiology compared to eyes with a posterior vitreous separation. No study has assessed PVDs in RVO patients receiving potential treatment.
- Being tested
- Ranibizumab
- Keywords
- RVO, PVD
- Medical subject headings
- Retinal Vein Occlusion, Vitreous Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Subjects will receive study medication ranibizumab 0.5mg. Re-treatment will occur monthly through 6 injections
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Experimental | Not described Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in BCVA at 6 months in the PVD positive and PVD negative ranibizumab-treated groups.
Measured: 6 months
Secondary outcomes (2)
To measure the mean change in central retinal thickness per OCT from baseline to Month 6 in PVD (+) and PVD (-) patients.
Measured: 6 months
To measure the mean change in leakage as determined by FA from baseline to Month 6 in PVD (+) and PVD (-) patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Vein 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 2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Model description
- BRVO and CRVO will be enrolled in this trial.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnes Retina Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Rhonda Weeks, Barnes Retina Institute
- Investigators
- Nancy M Holekamp, MD, Principal investigator, Barnes Retina Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831350
- Sponsor's protocol ID
- FVF4348s
- Other IDs
- 09-0049
- Acronym
- PADDLE
- Status last verified
- Oct 2017
- First submitted
- 27 Jan 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
- Posterior Vitreous Detachment (PVD) Assessment During Dual RVO Lucentis Evaluations (PADDLE Study)
- ClinicalTrials.gov ID
- NCT00831350
- Acronym / sponsor ID
- PADDLE / FVF4348s
- Keywords
- RVO, PVD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Barnes Retina InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 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 study of subjects with retinal vein occlusion (RVO) specifically looking at the difference in outcomes between patients with posterior vitreous detachment (PVD) and those without PVD. Posterior vitreous detachment is a condition where the gel-like substance that occupies the space between the retina and the lens of the eye liquefies and separates from the retina. 20 subjects from Barnes Retina Institute will be enrolled in this study. Based on a pre-treatment ultrasound (a test utilizing high-frequency sound waves to look at the inside of the eye), high resolution OCT (a noninvasive procedure called optical coherence tomography to check the thickness of your retina) and clinical exam, subjects will be assigned to one of 2 groups at baseline: Group 1 will be those with PVD and Group 2 will be those without PVD. Then subjects will receive monthly intravitreal (inside the eye) injections of Ranibizumab.
Detailed description
Several retinovascular diseases have been shown to be VEGF dependent including retinal vein occlusion, wet age-related macular degeneration, and diabetic retinopathy. The role of the vitreous or composition of the vitreous cavity has been examined in diabetic retinopathy on many occasions in the past and clinically it has been felt that a posterior vitreous separation leads a quieting and involution of diabetic retinopathy, both proliferative as well as pre-proliferative retinopathy. This clinical observation has never had any basic science data to support it. However, it has recently been shown that in cat eyes with posterior vitreous separation the vitreous cavity has a much lower VEGF concentration than in cat eyes with an attached posterior vitreous. This may be due to the fact that flow of oxygen from the retinal vasculature is increased by PVD. Vitreous oxygen levels are inversely associated with vitreous VEGF levels. As oxygen tension increases, VEGF levels will decline. This suggests if higher amounts of VEGF are present in the eye without PVD perhaps a powerful anti-VEGF drug, such as ranibizumab, may be of greater benefit to treat VEGF dependent retinovascular disease. To try and answer this question clinically, we have suggested that an analysis of the vitreous status in treatment naive eyes with retinal vein occlusion beginning ranibizumab therapy be undertaken to see if eyes without a posterior vitreous separation would achieve greater improvement in vision and a return to more normal retinal physiology compared to eyes with a posterior vitreous separation. No study has assessed PVDs in RVO patients receiving potential treatment.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- BRVO and CRVO will be enrolled in this trial.
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Experimental | Drug: Ranibizumab |
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
- Subjects of either gender, Age > 18 years
- Best corrected visual acuity in the study eye between 20/40 and 2/200 inclusive.
- Retinal venous occlusive disease (BRVO or CRVO)
- Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography, scheimpflug photography and high resolution OCT
Key exclusion criteria (19 listed)
- 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.
- Prior RVO in the study eye
- Duration of RVO greater than 6 months
- Laser photocoagulation for macular edema within 3 months of Day 0
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: LucentisSubjects will receive study medication ranibizumab 0.5mg. Re-treatment will occur monthly through 6 injections | Drug | ranibizumab |
Primary outcome
Mean change in BCVA at 6 months in the PVD positive and PVD negative ranibizumab-treated groups.
Time frame: 6 months
2 secondary outcomes
To measure the mean change in central retinal thickness per OCT from baseline to Month 6 in PVD (+) and PVD (-) patients.
Time frame: 6 months
To measure the mean change in leakage as determined by FA from baseline to Month 6 in PVD (+) and PVD (-) patients.
Time frame: 6 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.
Nancy M Holekamp, MD principal investigator
Barnes Retina Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab in people with Retinal Vein Occlusion and Posterior Vitreous Detachment, run by Barnes Retina Institute 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 6 inclusion and 19 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.
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 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?
Mean change in BCVA at 6 months in the PVD positive and PVD negative ranibizumab-treated groups. (time frame: 6 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.