Choroidal NeovascularizationPVDNCT01256632
Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy
A study testing Ranibizumab in people with Choroidal Neovascularization, run by Vision Research Foundation at 1 site in United States.
Trial summary
The primary objective: *To measure the difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative group. Secondary Objective: To measure the mean change in visual acuity from Baseline to Month 12. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Choroidal Neovascularization
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2010
- Phase
- Interventional
- 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 50 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
- Subjects of either gender, Age greater than or equal to 50 years
- Best corrected visual acuity in the study eye between 20/25 and 20/320
- Subfoveal choroidal neovascularization, secondary to age related macular degeneration
- Total lesion size less than 4 disc diameters
- 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
- 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.
- Patients with any form of prior eye treatment for AMD including: Photodynamic Therapy, anti-VEGF Therapy, Laser, Vitreoretinal surgery
- Had ocular surgery within the past 60 days in study eye
- Concurrent use of more than two therapies for glaucoma
- Uncontrolled glaucoma in the study eye(defined as intraocular pressure>30mm Hg despite treatment with anti-glaucoma medication)
Show all 14Show fewer
- Concurrent use of systemic anti-VEGF agents
- Has active infection in the study eye(s)
- Inability to obtain photographs to document CNV
- 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 sodium fluorescein dye
- Inability to comply with study or follow-up procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Vision Research Foundation
Royal Oak, Michigan, 48073
About this study
The primary objective:
*To measure the difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative group.
Secondary Objective:
- To measure the mean change in visual acuity from Baseline to Month 12.
- To measure the mean change in central retinal thickness per OCT from Baseline to Month 12
Read the detailed description
This is an open-label study, of intravitreally administered Ranibizumab in eyes with Age-related Macular Degeneration (AMD), specifically looking at the correlation between the presence of Posterior Vitreous Detachment(PVD) and the number of intravitreal injections of Ranibizumab required. 40 subjects from the offices of Vision Research Foundation will be enrolled in this study. Subjects will be assigned to either a Posterior Vitreous Detachment (PVD) positive group or a Posterior Vitreous Detachment (PVD) negative group based on a pre-treatment ultrasound. A maximum of 20 subjects in each group will be enrolled. Subject accrual into the trial is expected to be completed within 6 months.
All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed basis, based on predefined criteria. Eyes will be evaluated with a full ocular examination, visual acuity measurement (ETDRS chart at a distance of 4 meters),OCT,FA,Fundus Photos, B-scan Ultrasound and subject adverse event monitoring.
- Conditions
- Choroidal Neovascularization
- Being tested
- Ranibizumab
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
All study eyes will receive 0.5mg, of intravitreous monthly injections of ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after.
| Study group | Role | What they receive |
|---|---|---|
| Subfoveal CNV, secondary to AMD with PVD | Active comparator | 20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, with Posterior Vitreous Detachment (PVD Positive). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after. Receives: Drug: Ranibizumab |
| Subfoveal CNV, secondary to AMD w/o PVD | Active comparator | 20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, without Posterior Vitreous Detachment (PVD Negative). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed basis, based on predefined criteria. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment positive and Posterior Vitreous Detachment negative group
Measured: 12 months
Secondary outcomes (1)
Mean change in visual acuity 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 posted8 Dec 2010 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vision Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Michael T. Trese, M.D., Vision Research Foundation
- Investigators
- Michael T Trese, MD, Principal investigator, Vision Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256632
- Sponsor's protocol ID
- FVF4316s
- Acronym
- PVD
- Status last verified
- Jun 2012
- First submitted
- 2 Dec 2010
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy
- ClinicalTrials.gov ID
- NCT01256632
- Acronym / sponsor ID
- PVD / FVF4316s
- Conditions
- Choroidal Neovascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vision Research FoundationUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 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 primary objective:
*To measure the difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative group.
Secondary Objective:
- To measure the mean change in visual acuity from Baseline to Month 12.
- To measure the mean change in central retinal thickness per OCT from Baseline to Month 12
Detailed description
This is an open-label study, of intravitreally administered Ranibizumab in eyes with Age-related Macular Degeneration (AMD), specifically looking at the correlation between the presence of Posterior Vitreous Detachment(PVD) and the number of intravitreal injections of Ranibizumab required. 40 subjects from the offices of Vision Research Foundation will be enrolled in this study. Subjects will be assigned to either a Posterior Vitreous Detachment (PVD) positive group or a Posterior Vitreous Detachment (PVD) negative group based on a pre-treatment ultrasound. A maximum of 20 subjects in each group will be enrolled. Subject accrual into the trial is expected to be completed within 6 months.
All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed basis, based on predefined criteria. Eyes will be evaluated with a full ocular examination, visual acuity measurement (ETDRS chart at a distance of 4 meters),OCT,FA,Fundus Photos, B-scan Ultrasound and subject adverse event monitoring.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subfoveal CNV, secondary to AMD with PVD | Active comparator | Drug: Ranibizumab20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, with Posterior Vitreous Detachment (PVD Positive). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after. |
| Subfoveal CNV, secondary to AMD w/o PVD | Active comparator | Drug: Ranibizumab20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, without Posterior Vitreous Detachment (PVD Negative). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed basis, based on predefined criteria. |
Who may qualify
- Ages
- 50 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
- Subjects of either gender, Age greater than or equal to 50 years
- Best corrected visual acuity in the study eye between 20/25 and 20/320
- Subfoveal choroidal neovascularization, secondary to age related macular degeneration
- Total lesion size less than 4 disc diameters
Key exclusion criteria (14 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.
- Patients with any form of prior eye treatment for AMD including: Photodynamic Therapy, anti-VEGF Therapy, Laser, Vitreoretinal surgery
- Had ocular surgery within the past 60 days in study eye
- Concurrent use of more than two therapies for glaucoma
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: LucentisAll study eyes will receive 0.5mg, of intravitreous monthly injections of ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after. | Drug | Subfoveal CNV, secondary to AMD w/o PVD, Subfoveal CNV, secondary to AMD with PVD |
Primary outcome
Difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment positive and Posterior Vitreous Detachment negative group
Time frame: 12 months
1 secondary outcome
Mean change in visual acuity from Baseline to Month 12
Time frame: 12 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 28 Jun 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.
Michael T Trese, MD principal investigator
Vision Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranibizumab in people with Choroidal Neovascularization, run by Vision Research Foundation 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 14 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 28 Jun 2012. 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.
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?
Difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment positive and Posterior Vitreous Detachment negative group (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 28 Jun 2012.