Neovascular Polypoidal Choroidal VasculopathyPhase 4RIVALNCT02092532
Intravitreal Aflibercept for Neovascular Polypoidal Choroidal Vasculopathy (RIVAL Trial)
A Phase 4 study testing Rescue Intravitreal Aflibercept Injection and Rescue Therapy with PDT, Laser or Intravitreal Steroids in people with Neovascular Polypoidal Choroidal Vasculopathy, run by Southeast Retina Center, Georgia at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neovascular Polypoidal Choroidal Vasculopathy
- What is being tested?
- Rescue Intravitreal Aflibercept Injection and Rescue Therapy with PDT, Laser or Intravitreal Steroids
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control
- ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid
- Best corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity at 4 meters between 20/20 - 20/400 (BCVA ETDRS letter score 85 - 20 letters in the study eye)
- Lesion Characteristics - leaking lesions consistent with PCV. (No limitations on hemorrhage, fibrosis or atrophy)
- Clear ocular media to allow for photography/angiography
- Willing and able to comply with clinic visits and study-related procedures
- Patients with bilateral disease will only be able to enroll one eye
- Provide signed informed consent
Who cannot join
- Any history of systemic Anti-VEGF therapy
- Current ocular or periocular infection
- Active intraocular inflammation
- Any comorbid condition that may decrease visual acuity
- Any patients who have had intraocular surgery within the past 30 days for any condition
- For treatment naïve patients: No prior anti-VEGF, PDT, intravitreal steroids or laser (subfoveal or non foveal)
Show all 21Show fewer
- For previously-treated patients :
- Prior anti-VEGF (ranibizumab, bevacizumab, pegaptanib) within 30 days
- Prior IAI
- Prior PDT , transpupillary thermal therapy (TTT) or radiation within 90 days (a maximum of 3 PDTs allowed)
- Prior intravitreal steroids within 90 days
- Prior non-foveal laser within 90 days
- Prior subfoveal laser
- Patients with features of dry age-related macular degeneration such as abundant drusen and symptoms/demographic features inconsistent with the diagnosis of PCV
- Allergy to fluorescein, ICG, iodine, shellfish
- Any other condition that the investigator believes would pose a significant hazard to the patient if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- History of previous subfoveal laser
- Advanced glaucoma (IOP > 25 or cup/disc ratio > 0.8)
- Pregnant or breast-feeding women
- Sexually active men* or women of childbearing potential who are unwilling to practice adequate contraception during the study (adequate contraceptive 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
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southeast Retina Center, PC
Augusta, Georgia, 30909
Dennis M Marcus, MD, 706-650-0061, dmarcus@southeastretina.com
Jared Gardner, BS, 706-650-0061, jgardner@southeastretina.com
About this study
Official title: Open-label, Non-randomized, Unmasked, Study of IAI in Patients Which Choroidal Neovascularization Secondary to Polypoidal Choroidal Vasculopathy (PCV)
The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.
Read the detailed description
This is an open-label, non-randomized, unmasked, study of IAI in patients with choroidal neovascularization secondary to polypoidal choroidal vasculopathy (PCV). Twenty treatment naïve and previously treated PCV eyes will be enrolled (only one study eye per patient will be enrolled). A maximum of 10 previously treated eyes will be enrolled. Consented, enrolled patients will be followed monthly. All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. Starting at Month 3, patients can receive non-anti vascular endothelial growth factor (VEGF) rescue therapy (ie: Photodynamic Therapy (PDT), laser, intravitreal steroids) if the pre-defined criteria are met.
- Being tested
- Rescue Intravitreal Aflibercept Injection, Rescue Therapy with PDT, Laser or Intravitreal Steroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rescue Intravitreal Aflibercept InjectionDrug
Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met.
Rescue Therapy with PDT, Laser or Intravitreal SteroidsProcedure or surgery
Starting at Month 3, patients can receive non-anti VEGF rescue therapy (ie: PDT, laser, intravitreal steroids) if the pre-defined criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Aflibercept Injection | Other | All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. Receives: Drug: Rescue Intravitreal Aflibercept Injection; Procedure: Rescue Therapy with PDT, Laser or Intravitreal Steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity
The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 6.
Measured: Month 6
Incidence and Severity
The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 12.
Measured: Month 12
Secondary outcomes (10)
Change in Best Corrected Visual Acuity (BCVA)
•The mean change in BCVA from Baseline to Month 6 and from Baseline up to 12 months
Measured: Months 6 and 12
Change in Best Corrected Visual Acuity (BCVA)
•Proportion of patients gaining 5, 10 and 15 letters at Months 6 and 12
Measured: Months 6 and 12
Change in Best Corrected Visual Acuity (BCVA)
•Proportion of patients losing 5,10, and 15 letters at Months 6 and 12
Measured: Months 6 and 12
Photography Assessments
•Mean change from baseline in central subfield thickness at Months 6 and 12 as assessed on spectral domain optical coherence tomography (SD-OCT)
Measured: Months 6 and 12
Photography Assessments
•Mean change from baseline in macular volume at Months 6 and 12 as assessed on SD-OCT
Measured: Months 6 and 12
Photography Assessments
•Mean change from baseline in choroidal thickness at Months 6 and 12 through SD-OCT
Measured: Months 6 and 12
Photography Assessments
•Proportion of patients with no evidence of pigment epithelial detachment (PED), intraretinal and subretinal fluid from choroidal neovascularization (CNV) as assessed by optical coherence tomography (OCT) at 6 and 12 months
Measured: Months 6 and 12
Photography Assessments
•Mean change from baseline in the total area of CNV fluorescein angiographic leakage at months 6 and 12
Measured: Months 6 and 12
Photography Assessments
•Fluorescein angiograms, indocyanine green (ICG) angiograms, OCT and fundus photographs at Months 6 and 12 compared to baseline as unchanged, resolved, improved, worsened, or cannot determine. See section 9.1.2.2
Measured: Months 6 and 12
Photography Assessments
•Rate of polyp regression and resolution at 6 and 12 Months
Measured: Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Polypoidal Choroidal VasculopathyStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast Retina Center, Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Dennis M Marcus, MD, Principal investigator, Part-Owner of Southeast Retina Center, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092532
- Sponsor's protocol ID
- VGFTe-AMD-1401
- Acronym
- RIVAL
- Status last verified
- Oct 2014
- First submitted
- 13 Mar 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomized, Unmasked, Study of IAI in Patients Which Choroidal Neovascularization Secondary to Polypoidal Choroidal Vasculopathy (PCV)
- ClinicalTrials.gov ID
- NCT02092532
- Acronym / sponsor ID
- RIVAL / VGFTe-AMD-1401
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Southeast Retina Center, GeorgiaUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 20 Mar 2014 (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 safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.
Detailed description
This is an open-label, non-randomized, unmasked, study of IAI in patients with choroidal neovascularization secondary to polypoidal choroidal vasculopathy (PCV). Twenty treatment naïve and previously treated PCV eyes will be enrolled (only one study eye per patient will be enrolled). A maximum of 10 previously treated eyes will be enrolled. Consented, enrolled patients will be followed monthly. All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. Starting at Month 3, patients can receive non-anti vascular endothelial growth factor (VEGF) rescue therapy (ie: Photodynamic Therapy (PDT), laser, intravitreal steroids) if the pre-defined criteria are met.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Aflibercept Injection | Other | Drug: Rescue Intravitreal Aflibercept Injection, Procedure: Rescue Therapy with PDT, Laser or Intravitreal SteroidsAll patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females ≥ 18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control
- ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid
- Best corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity at 4 meters between 20/20 - 20/400 (BCVA ETDRS letter score 85 - 20 letters in the study eye)
- Lesion Characteristics - leaking lesions consistent with PCV. (No limitations on hemorrhage, fibrosis or atrophy)
- Clear ocular media to allow for photography/angiography
Key exclusion criteria (21 listed)
- Any history of systemic Anti-VEGF therapy
- Current ocular or periocular infection
- Active intraocular inflammation
- Any comorbid condition that may decrease visual acuity
- Any patients who have had intraocular surgery within the past 30 days for any condition
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 |
|---|---|---|
| Rescue Intravitreal Aflibercept InjectionPatients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. | Drug | Intravitreal Aflibercept Injection |
| Rescue Therapy with PDT, Laser or Intravitreal SteroidsStarting at Month 3, patients can receive non-anti VEGF rescue therapy (ie: PDT, laser, intravitreal steroids) if the pre-defined criteria are met. | Procedure or surgery | Intravitreal Aflibercept Injection |
Primary outcome
Incidence and Severity
Time frame: Month 6
The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 6.
Incidence and Severity
Time frame: Month 12
The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 12.
10 secondary outcomes
Change in Best Corrected Visual Acuity (BCVA)
Time frame: Months 6 and 12
Change in Best Corrected Visual Acuity (BCVA)
Time frame: Months 6 and 12
Change in Best Corrected Visual Acuity (BCVA)
Time frame: Months 6 and 12
Photography Assessments
Time frame: Months 6 and 12
Photography Assessments
Time frame: Months 6 and 12
Photography Assessments
Time frame: Months 6 and 12
Photography Assessments
Time frame: Months 6 and 12
Photography Assessments
Time frame: Months 6 and 12
Photography Assessments
Time frame: Months 6 and 12
Photography Assessments
Time frame: Months 6 and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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.
Dennis M Marcus, MD principal investigator
Part-Owner of Southeast Retina Center, PC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rescue Intravitreal Aflibercept Injection and Rescue Therapy with PDT, Laser or Intravitreal Steroids in people with Neovascular Polypoidal Choroidal Vasculopathy, run by Southeast Retina Center, Georgia 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 21 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 15 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 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 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?
Contact Siobhan Ortiz (706-650-0061, siobhan@southeastretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity (time frame: Month 6). The study lists 2 primary outcomes in all. 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 15 Oct 2014.