Choroidal Retinal NeovascularizationPhase 4AflibxMyopiaNCT02033018
Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization
A Phase 4 study testing Aflibercept Injection in people with Choroidal Retinal Neovascularization, run by Instituto de Olhos de Goiania at 2 sites in Brazil.
Trial summary
The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Choroidal Retinal Neovascularization
- 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
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- Oct 2013to Nov 2014
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Myopic and CNVM
Who cannot join
- Patients with poor compliance
- Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients).
- Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
- Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
- Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
- Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
- Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
Trial locations and contacts
2 sites in 1 country.
Raquel Monteiro contact
Brazil2 sites, 1 recruiting
- Active, not recruiting
Instituto de Olhos de Goiania
Goiânia, Goiás, 74120-050
- Recruiting
Instituto de Olhos de Goiania
Goiânia, Goiás, 74120-050
Raquel Monteiro, 55 62 3220 2511
João J Nassaralla, JR, 55 62 3220 2545, nassaral@terra.com.br
About this study
The purpose of this study is to evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary
Read the detailed description
Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months
- Conditions
- Choroidal Retinal Neovascularization
- Being tested
- Aflibercept Injection
- Keywords
- Aflibercept, Myopia, Complications, Neovascularization, OCT
- Medical subject headings
- Myopia, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept InjectionDrug
Also called Aflibercept intravitreal injection of 0,5 mg ( 0.05mL
Aflibercept intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept injection | Experimental | Myopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection Receives: Drug: Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. AII were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 1 year.
Measured: To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.
Secondary outcomes (1)
Safety and Tolerability
8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed.
Measured: To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal Retinal 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joao J Nassaralla, Jr, Study chair, Instituto de Olhos de Goiânia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033018
- Sponsor's protocol ID
- JJ - 3/2013
- Acronym
- AflibxMyopia
- Status last verified
- Jan 2014
- First submitted
- 31 Dec 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aflibercept Intravitreal Injection for Myopic Choroidal Neovascularization
- ClinicalTrials.gov ID
- NCT02033018
- Acronym / sponsor ID
- AflibxMyopia / JJ - 3/2013
- Conditions
- Choroidal Retinal Neovascularization
- Keywords
- Aflibercept, Myopia, Complications, Neovascularization, OCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 10 Jan 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 clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary
Detailed description
Twenty consecutive patients (30 eyes) with subfoveal PM-CNV, 9 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept injection | Experimental | Drug: Aflibercept InjectionMyopic eyes with retinal neovascularization submitted a aflibercept intravitreal injection |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myopic and CNVM
Key exclusion criteria (7 listed)
- Patients with poor compliance
- Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (< one year). (Physician clearance was obtained for all patients).
- Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
- Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
- Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
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: Aflibercept intravitreal injection of 0,5 mg ( 0.05mLAflibercept intravitreal injection | Drug | Aflibercept injection |
Primary outcome
Efficacy
Time frame: To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.
8 patients with subfoveal PM-CNV, were treated with of 2 mg ( 0.05mL) RII. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. AII were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 1 year.
1 secondary outcome
Safety and Tolerability
Time frame: To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 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.
Raquel Monteiro contact
Joao J Nassaralla, Jr study chair
Instituto de Olhos de Goiânia
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 Injection in people with Choroidal Retinal Neovascularization, run by Instituto de Olhos de Goiania at 2 sites in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. 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 Brazil. 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 Raquel Monteiro (55 62 3220 2500), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: To evaluate the clinical results of aflibercept intravitreal injection (AII) in choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV), after 1 year follow up.). 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 2014.