Exudative Age-Related Macular DegenerationELOUANNCT02089503
Monocentric Retrospective Observational Study on Patients With Macular Degeneration
An observational study of Exudative Age-Related Macular Degeneration, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Exudative Age-Related Macular Degeneration
- What is being tested?
- intravitreal injections of Lucentis
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Dec 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care
Who may be able to join
- Patients with exudative-subfove ARMD, regardless the neovessel type or the initial visual acuity; 2 - Patients treated in the department with intra vitreous injection of Lucentis ® during the study period (08/2011 and 02/2013); 3 - If both eyes are eligible, both will be analyzed;
Who cannot join
- - Patients who received, for the studied eye, a treatment with a Vascular endothelial growth factor (VEGF) other than Lucentis ® in the three months preceding the start of the study. For those who received combination therapy, the nature of the treatment will be specified and taken into account in the subgroups for statistical analyzes;
- - Patients with high myopia or neovessel not related to exudative-ARMD;
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Saint Joseph
Marseille, 13008
Frederic QUEGUINER, MD
Frederic QUEGUINER, MD
About this study
Official title: Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.
Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
- Being tested
- intravitreal injections of Lucentis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injections of LucentisOther
intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use
| Study group | Role | What they receive |
|---|---|---|
| induction phase + intravitreal inj. | Group of patients who received Lucentis ® with induction phase Receives: Other: intravitreal injections of Lucentis | |
| intravitreal inj. without induction | Group of patients who received Lucentis ® without induction phase Receives: Other: intravitreal injections of Lucentis | |
| intravitreal inj. + monthly follow-up | group of patients who were monthly monitored (+/- 1 week) Receives: Other: intravitreal injections of Lucentis | |
| intravitreal inj. + follow-up :> 1 month | group of patients with Follow up visits intervals> 1 month (+/- 1 week) Receives: Other: intravitreal injections of Lucentis | |
| intravitreal inj +induction+ month. FU | Group of patients who received Lucentis with induction phase and who were monthly monitored (+/- 1 week) Receives: Other: intravitreal injections of Lucentis | |
| date Lucentis® 1st intravitreal Inj. | Group of patients selected in accordance with the date of Lucentis® treatment start. Receives: Other: intravitreal injections of Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
Measured: measured at 24 months (± 4 weeks)
Secondary outcomes (1)
the mean change of the BCVA throughout the 24 months of follow-up (FU),
Measured: 24 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, QUEGUINER, MD, Hospital St. Joseph, Marseille, France
- Investigators
- Maud RIGHINI, MD, Study chair, HSJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089503
- Sponsor's protocol ID
- ELOUAN HSJ 2014
- Acronym
- ELOUAN
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.
- ClinicalTrials.gov ID
- NCT02089503
- Acronym / sponsor ID
- ELOUAN / ELOUAN HSJ 2014
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 17 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.
Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| induction phase + intravitreal inj. | – | Other: intravitreal injections of LucentisGroup of patients who received Lucentis ® with induction phase |
| intravitreal inj. without induction | – | Other: intravitreal injections of LucentisGroup of patients who received Lucentis ® without induction phase |
| intravitreal inj. + monthly follow-up | – | Other: intravitreal injections of Lucentisgroup of patients who were monthly monitored (+/- 1 week) |
| intravitreal inj. + follow-up :> 1 month | – | Other: intravitreal injections of Lucentisgroup of patients with Follow up visits intervals> 1 month (+/- 1 week) |
| intravitreal inj +induction+ month. FU | – | Other: intravitreal injections of LucentisGroup of patients who received Lucentis with induction phase and who were monthly monitored (+/- 1 week) |
| date Lucentis® 1st intravitreal Inj. | – | Other: intravitreal injections of LucentisGroup of patients selected in accordance with the date of Lucentis® treatment start. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care
Key inclusion criteria (1 listed)
- Patients with exudative-subfove ARMD, regardless the neovessel type or the initial visual acuity; 2 - Patients treated in the department with intra vitreous injection of Lucentis ® during the study period (08/2011 and 02/2013); 3 - If both eyes are eligible, both will be analyzed;
Key exclusion criteria (2 listed)
- - Patients who received, for the studied eye, a treatment with a Vascular endothelial growth factor (VEGF) other than Lucentis ® in the three months preceding the start of the study. For those who received combination therapy, the nature of the treatment will be specified and taken into account in the subgroups for statistical analyzes;
- - Patients with high myopia or neovessel not related to exudative-ARMD;
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 |
|---|---|---|
| intravitreal injections of Lucentisintravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use | Other | date Lucentis® 1st intravitreal Inj., induction phase + intravitreal inj., intravitreal inj +induction+ month. FU, intravitreal inj. + follow-up :> 1 month, intravitreal inj. + monthly follow-up, intravitreal inj. without induction |
Primary outcome
Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
Time frame: measured at 24 months (± 4 weeks)
1 secondary outcome
the mean change of the BCVA throughout the 24 months of follow-up (FU),
Time frame: 24 months of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 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.
Maud RIGHINI, MD study chair
HSJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exudative Age-Related Macular Degeneration, run by Hospital St. Joseph, Marseille, France at 1 site 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 1 inclusion and 2 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 18 Mar 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 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.
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 Frederic QUEGUINER, MD (+33491806793, fqueguiner@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks). (time frame: measured at 24 months (± 4 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 18 Mar 2014.