Age Related Macular DegenerationPhase 4ROLLNCT01670162
On-label tReatment With Intravitreal Aflibercept injectiOn for Patients With Persistent Pigment epitheliaL Detachments in Neovascular Age Related Macular Degeneration (AMD)
A Phase 4 study testing Aflibercept in people with Age Related Macular Degeneration and Pigment Epithelial Detachment, run by Tennessee Retina at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration, Pigment Epithelial Detachment
- What is being tested?
- Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2012to Jan 2016
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous enrollment in the study evaluating 2.0mg ranibizumab (NCT 01189019) without early study discontinuation. The last treatment* in the study eye should have been received at least 30 days before enrollment in this study.
- last study treatment of either 1.0mg or 2.0mg ranibizumab
- Presence of persistent fibrovascular pigment epithelial detachment Willing and able to comply iwth clinic visits and study related procedures Provide signed informed consent
Who cannot join
- Prior treatment with verteporfin, or external beam radiation therapy, or transpupillary thermotherapy in the study eye.
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye.
- History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye.
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g. diabetic retinopathy, advanced glaucoma).
- Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 12 month study period.
- Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or auto-immune associated uveitis in either eye.
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- Current vitreous hemorrhage in the study eye.
- History of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye.
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
- Aphakia, anterior chamber intraocular lens (ACIOL) or unstable posterior chamber intraocular lens (PCIOL).
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure equal to or greater than 30 despite treatment with anti-glaucoma medication).
- Pregnant or breastfeeding women.
- Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraception measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam or jelly).
- Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Retina Associates of Kentucky
Lexington, Kentucky, 40509
Tennessee Retina, P.C.
Nashville, Tennessee, 37203
Pacific Eye Associates
San Francisco, California, 94115
About this study
Official title: On-label tReatment With Intravitreal Aflibercept Injection for Patients With Persistent Pigment Epithelial Detachments in Neovascular AMD.
The purpose of this study is to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs.
Read the detailed description
A Phase 4 study to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs (the ROLL study).
- Being tested
- Aflibercept
- Keywords
- Pigment Epithelium of Eye, Wet macular degeneration, Macular degeneration
- Medical subject headings
- Macular Degeneration, Retinal Detachment, Wet Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Also called VEGF-Trap, Eylea
Intravitreal Injection 2mg/0.05mL Aflibercept
| Study group | Role | What they receive |
|---|---|---|
| 3 loading doses, then every 2 months | Experimental | All patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly. Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with flattening of PED
Measured: 12 months
Secondary outcomes (10)
Mean Change in Best Corrected Visual Acuity (BCVA)
Measured: 6 month timepoint and 12 month timepoints
Proportion of patients with flattening of PED
Measured: 6 months
Proportion of patients with flattening of PED
Measured: 18 month and 24 month timepoints
Mean number of injections needed
Measured: 12 month period
Mean change in Optical Coherence Tomography (OCT) central retinal thickness
Measured: 6 month and 12 month timepoints
Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Measured: 6 month and 12 month timepoint
Mean change in BCVA
Measured: 18 month and 24 month timepoint
Mean number of injections
Measured: during year 2
Mean change in OCT central retinal thickness
Measured: 18 month and 24 month timepoints
Proportion of patients gaining 5 letters or more
Measured: 18 month and 24 month timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2015 (estimated)
- Study completionJan 2016 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tennessee Retina
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Brandon G Busbee, MD, Principal investigator, Tennessee Retina, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670162
- Sponsor's protocol ID
- VGFT-OD-1220
- Acronym
- ROLL
- Status last verified
- Oct 2014
- First submitted
- 17 Aug 2012
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-label tReatment With Intravitreal Aflibercept Injection for Patients With Persistent Pigment Epithelial Detachments in Neovascular AMD.
- ClinicalTrials.gov ID
- NCT01670162
- Acronym / sponsor ID
- ROLL / VGFT-OD-1220
- Keywords
- Pigment Epithelium of Eye, Wet macular degeneration, Macular degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tennessee RetinaUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Aug 2012
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 21 Aug 2012 (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 efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs.
Detailed description
A Phase 4 study to evaluate the efficacy and safety of intravitreal aflibercept injection in a population of neovascular AMD patients that have been previously treated with 2.0 mg ranibizumab for persistent PEDs (the ROLL study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 loading doses, then every 2 months | Experimental | Drug: AfliberceptAll patients will receive 3 monthly intravitreal aflibercept injections followed by mandatory dosing every 3 months. If needed, patients can be treated monthly. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previous enrollment in the study evaluating 2.0mg ranibizumab (NCT 01189019) without early study discontinuation. The last treatment* in the study eye should have been received at least 30 days before enrollment in this study.
- last study treatment of either 1.0mg or 2.0mg ranibizumab
- Presence of persistent fibrovascular pigment epithelial detachment Willing and able to comply iwth clinic visits and study related procedures Provide signed informed consent
Key exclusion criteria (14 listed)
- Prior treatment with verteporfin, or external beam radiation therapy, or transpupillary thermotherapy in the study eye.
- Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye.
- History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye.
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g. diabetic retinopathy, advanced glaucoma).
- Any concurrent intraocular condition in the study eye (e.g. diabetic retinopathy or glaucoma) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12 month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 12 month study period.
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 |
|---|---|---|
| AfliberceptAlso: VEGF-Trap, EyleaIntravitreal Injection 2mg/0.05mL Aflibercept | Drug | 3 loading doses, then every 2 months |
Primary outcome
Proportion of patients with flattening of PED
Time frame: 12 months
10 secondary outcomes
Mean Change in Best Corrected Visual Acuity (BCVA)
Time frame: 6 month timepoint and 12 month timepoints
Proportion of patients with flattening of PED
Time frame: 6 months
Proportion of patients with flattening of PED
Time frame: 18 month and 24 month timepoints
Mean number of injections needed
Time frame: 12 month period
Mean change in Optical Coherence Tomography (OCT) central retinal thickness
Time frame: 6 month and 12 month timepoints
Proportion of patients gaining 5 letters or more letters on Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Time frame: 6 month and 12 month timepoint
Mean change in BCVA
Time frame: 18 month and 24 month timepoint
Mean number of injections
Time frame: during year 2
Mean change in OCT central retinal thickness
Time frame: 18 month and 24 month timepoints
Proportion of patients gaining 5 letters or more
Time frame: 18 month and 24 month timepoints
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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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.
Brandon G Busbee, MD principal investigator
Tennessee Retina, PC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept in people with Age Related Macular Degeneration and Pigment Epithelial Detachment, run by Tennessee Retina at 3 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 3 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: status not confirmed, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients with flattening of PED (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 29 Oct 2014.