Type 3 Choroidal NeovascularizationPhase 4ATTRACTNCT02320474
Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
A Phase 4 study testing Aflibercept in people with Type 3 Choroidal Neovascularization, run by Poitiers University Hospital at 2 sites in France.
Trial summary
This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 3 Choroidal Neovascularization
- What is being tested?
- Aflibercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Nov 2014to Nov 2018
- 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
- Males or females aged more than 50 years
- Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
- Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
- Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
- Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality
Who cannot join
- Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
- Any previous history of intravitreal injections in the study eye for exudative AMD
- Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
- Any history of vitrectomy
- Media opacities preventing accurate imaging of the retina (cataract)
- Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole)
- Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Poitiers University Hospital
Poitiers, 86000
Polyclinic of POITIERS
Poitiers, 86000
About this study
This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.
- Conditions
- Type 3 Choroidal Neovascularization
- Being tested
- Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept | Experimental | Not described Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study start25 Nov 2014
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 3 Choroidal NeovascularizationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas LEVEZIEL, MD, PhD, Principal investigator, CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320474
- Sponsor's protocol ID
- ATTRACT
- Acronym
- ATTRACT
- Status last verified
- Mar 2019
- First submitted
- 10 Dec 2014
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)
- ClinicalTrials.gov ID
- NCT02320474
- Acronym / sponsor ID
- ATTRACT / ATTRACT
- Conditions
- Type 3 Choroidal Neovascularization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 25 Nov 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 19 Dec 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.
This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept | Experimental | Drug: Aflibercept |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females aged more than 50 years
- Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
- Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
- Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
- Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality
Key exclusion criteria (7 listed)
- Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
- Any previous history of intravitreal injections in the study eye for exudative AMD
- Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
- Any history of vitrectomy
- Media opacities preventing accurate imaging of the retina (cataract)
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 | Drug | Aflibercept |
Primary outcome
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Time frame: 52 weeks
Mean change from baseline in Best Corrected Visual Acuity (BCVA) as measured by ETDRS letter score at 4 meters
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 8 Mar 2019.
Related trials for Type 3 Choroidal Neovascularization
Not yet recruitingPhase 4
Long Term Efficacy of Faricimab Using a Treat and Extend Regimen for Type 3 Macular Neovascularization
Age-related Macular Degeneration (ARMD), Choroidal Neovascularization
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.
Nicolas LEVEZIEL, MD, PhD principal investigator
CHU Poitiers
2 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 Type 3 Choroidal Neovascularization, run by Poitiers University Hospital at 2 sites in France.
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 5 inclusion and 7 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 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
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 from baseline in Best Corrected Visual Acuity (BCVA) (time frame: 52 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 8 Mar 2019.