Neovascular Age-Related Macular DegenerationPhase 1/2I-TRAPNCT03594461
Intense Treatment Regimen With Intravitreal Aflibercept Injection
A Phase 1/2 study testing Aflibercept Injection in people with Neovascular Age-Related Macular Degeneration, run by Vitreous -Retina- Macula Consultants of New York at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- Aflibercept Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2018to Jun 2020
- Phase
- Phase 1/2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Choroidal neovascularization related to age-related macular degeneration
- Prior treatment with any anti-VEGF agent for ≥ 12 months
- Prior treatment with at least five consecutive IAI at baseline with an average treatment interval of maximum 35 days
- Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days following the most recent IAI
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- A patient who meets any of the following criteria will be excluded from the study:
- Monocular patients
- Patients with a previous history of macular thermal laser or PDT
- Confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal vascular occlusive disease)
- Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
Show all 15Show fewer
- Active intraocular inflammation (grade trace or above) in the study eye
- History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment
- Patients on systemic anti-VEGF treatment
- Pregnant or breastfeeding women
- Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception prior to the initial dose/start of the first treatment, during the study, and for at least 3 months after the last dose. 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; 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 childbearing 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
Vitreous Retina Macula Consultants of New York
New York, New York, 10022
Peggy Guerrero, 212-452-6965
K.Bailey Freund, MD
About this study
Official title: Intense Treatment Regimen With Intravitreal Aflibercept Injection for Refractory Neovascular Age-Related Macular Degeneration With or Without Polypoidal Choroidal Vasculopathy
This study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks
Read the detailed description
The development of biologic therapy targeting VEGF has been revolutionary and has lowered the rate of functional blindness in many developed countries. Modalities to treat nvAMD have been based on monthly dosing. For many patients, this modality is adequate and they can achieve a dry macula. A subset of patients can even have their treatment intervals extended. There is, however, a subset of patients with recalcitrant neovascularization for whom IAI fails to produce a dry macula even with q4w dosing. An intense dosing schedule for a short period of time could decrease fluid activity in these patients.
- Being tested
- Aflibercept Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept InjectionDrug
Also called Eylea
Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy
| Study group | Role | What they receive |
|---|---|---|
| 2mg IAI q2w | Experimental | 2mg Intravitreal Aflibercept injection will be given every 2 weeks starting at baseline and then at weeks 2, 4, 6, 8, 10 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52. Receives: Drug: Aflibercept Injection |
| 2mg IAI q3w | Experimental | 2mg Intravitreal Aflibercept injection will be given every 3 weeks starting at baseline and then at weeks 3, 6, 9 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52. Receives: Drug: Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy
Measured: Baseline to 12 weeks
Secondary outcomes (13)
Mean change in BCVA from baseline to week 12
Measured: Baseline to week 12
Mean change in BCVA from baseline to week 52
Measured: Baseline to week 52
Number of patients who are able to maintain a dry macula with IAI intervals extending beyond q4w.
Measured: Baseline to week 52
Mean number of injections to achieve fluid-free status and at week 12 and week 52
Measured: Baseline to week 52
Incidence and severity of adverse events through week 52
Measured: Baseline to week 52
Polyp size reduction or closure - compare polyp and lesion area size to baseline on Heidelberg Eye Explorer software (Tan 2015), OCTA and ICG angiography (ICGA)
Measured: Baseline to week 52
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Measured: Baseline to week 12
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Measured: Baseline to week 52
Mean change in lesion
Measured: Baseline to week 12
Mean change in lesion
Measured: Baseline to week 52
Number of patients whose fovea remain dry upon extending to q4w IAI at week 52
Measured: Baseline to week 52
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Measured: Baseline to week 12
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Measured: Baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start11 Sep 2018
- Primary completionMar 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- K. Bailey Freund, MD, Principal investigator, Vitreous -Retina- Macula Consultants of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594461
- Sponsor's protocol ID
- I-TRAP
- Acronym
- I-TRAP
- Status last verified
- Jan 2019
- First submitted
- 9 Jul 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense Treatment Regimen With Intravitreal Aflibercept Injection for Refractory Neovascular Age-Related Macular Degeneration With or Without Polypoidal Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT03594461
- Acronym / sponsor ID
- I-TRAP / I-TRAP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vitreous -Retina- Macula Consultants of New YorkUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 20 Jul 2018 (actual)
- 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 study will evaluate the safety and efficacy of intense dosing for a limited period in patients who demonstrate refractory disease on monthly IAI. Patients will be followed for 52 weeks
Detailed description
The development of biologic therapy targeting VEGF has been revolutionary and has lowered the rate of functional blindness in many developed countries. Modalities to treat nvAMD have been based on monthly dosing. For many patients, this modality is adequate and they can achieve a dry macula. A subset of patients can even have their treatment intervals extended. There is, however, a subset of patients with recalcitrant neovascularization for whom IAI fails to produce a dry macula even with q4w dosing. An intense dosing schedule for a short period of time could decrease fluid activity in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2mg IAI q2w | Experimental | Drug: Aflibercept Injection2mg Intravitreal Aflibercept injection will be given every 2 weeks starting at baseline and then at weeks 2, 4, 6, 8, 10 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52. |
| 2mg IAI q3w | Experimental | Drug: Aflibercept Injection2mg Intravitreal Aflibercept injection will be given every 3 weeks starting at baseline and then at weeks 3, 6, 9 and 12. Patients will then be seen at week 16 (4 weeks following the end of the intensive dosing period), and a treat and extend regimen will be initiated through week 52. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 50 years
- Choroidal neovascularization related to age-related macular degeneration
- Prior treatment with any anti-VEGF agent for ≥ 12 months
- Prior treatment with at least five consecutive IAI at baseline with an average treatment interval of maximum 35 days
- Presence of foveal fluid at most recent clinical visit occurring 30 (+/- 5) days following the most recent IAI
Key exclusion criteria (15 listed)
- Monocular patients
- Patients with a previous history of macular thermal laser or PDT
- Confounding ocular conditions in the study eye that may affect interpretation of OCT, BCVA or assessment of macular appearance (eg. cataract, epiretinal membrane, retinal vascular occlusive disease)
- Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding baseline
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study 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 |
|---|---|---|
| Aflibercept InjectionAlso: EyleaIntense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy | Drug | 2mg IAI q2w, 2mg IAI q3w |
Primary outcome
Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy
Time frame: Baseline to 12 weeks
13 secondary outcomes
Mean change in BCVA from baseline to week 12
Time frame: Baseline to week 12
Mean change in BCVA from baseline to week 52
Time frame: Baseline to week 52
Number of patients who are able to maintain a dry macula with IAI intervals extending beyond q4w.
Time frame: Baseline to week 52
Mean number of injections to achieve fluid-free status and at week 12 and week 52
Time frame: Baseline to week 52
Incidence and severity of adverse events through week 52
Time frame: Baseline to week 52
Polyp size reduction or closure - compare polyp and lesion area size to baseline on Heidelberg Eye Explorer software (Tan 2015), OCTA and ICG angiography (ICGA)
Time frame: Baseline to week 52
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Time frame: Baseline to week 12
Mean change to area of flow within neovascular network on OCT-angiography (OCTA)
Time frame: Baseline to week 52
Mean change in lesion
Time frame: Baseline to week 12
Mean change in lesion
Time frame: Baseline to week 52
Number of patients whose fovea remain dry upon extending to q4w IAI at week 52
Time frame: Baseline to week 52
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Time frame: Baseline to week 12
Number of patients whose subfoveal fluid is resolved or with no further increase in extrafoveal fluid
Time frame: Baseline to week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
K. Bailey Freund, MD principal investigator
Vitreous -Retina- Macula Consultants of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aflibercept Injection in people with Neovascular Age-Related Macular Degeneration, run by Vitreous -Retina- Macula Consultants of New York 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 7 inclusion and 15 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 10 Jan 2019. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sariah Ramoutar Persaud (2124526929, sariahpersaud@vrmny.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of ocular and non ocular adverse events through to week 12 of intensive IAI therapy (time frame: Baseline to 12 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 10 Jan 2019.