Central Retinal Vein OcclusionPhase 4CHIC-3NCT01448018
Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion
A Phase 4 study testing ranibizumab and hemodilution in people with Central Retinal Vein Occlusion, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial summary
The purpose of this study is to compare ranibizumab injection to hemodilution at the early phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both treatments may have a synergic effect. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Central Retinal Vein Occlusion
- What is being tested?
- ranibizumab and hemodilution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2010to Dec 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRVO confirmed by fluorescein angiography
- duration from onset of 1 month or less
- visual acuity of 20/32 or less
Who cannot join
- neovascular complication
- extensive retinal ischemia requiring prompt panretinal photocoagulation
- hematocrit level lower than 38%
- previous laser or surgery in the study eye, etc
Trial locations and contacts
2 sites in 1 country.
France2 sites
Intercommunal Hospital
Créteil, 94000
Pitie-Salpetriere Hospital
Paris, 75013
About this study
Official title: Pilot Study on Efficacy and Tolerance of Intravitreous Injection of Ranibizumab (Lucentis®) in Early-onset Central Retinal Vein Occlusion in Comparison to Hemodilution Using Erythrocytapheresis
The purpose of this study is to compare ranibizumab injection to hemodilution at the early phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both treatments may have a synergic effect.
Read the detailed description
Patients with recent-onset CRVO (lasting for less than 1 month)are randomly assigned to one of 3 groups: hemodilution using erythrocytapheresis alone, 3 monthly injection of ranibizumab alone, or both.
Patients are followed monthly during the 6-month study.
- Conditions
- Central Retinal Vein Occlusion
- Being tested
- ranibizumab, hemodilution
- Medical subject headings
- Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
3 monthly intravitreous injection as soon as possible after the inclusion
hemodilutionProcedure or surgery
hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Active comparator | patients in this arm receive 3 monthly injection of ranibizumab Receives: Drug: ranibizumab |
| Hemodilution | Active comparator | hemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%) Receives: Procedure: hemodilution |
| ranibizumab and hemodilution | Active comparator | patients receive both treatments Receives: Drug: ranibizumab; Procedure: hemodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months
Measured: 6 months
Secondary outcomes (1)
Gain in visual acuity of 2 ETDRS-lines or more
Number of patients who gained 2 lines or more between baseline and the 6-month visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Retinal Vein OcclusionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Glacet-Bernard, Centre Hospitalier Intercommunal Creteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448018
- Sponsor's protocol ID
- 2009-011403-23
- Other IDs
- 2009
- Acronym
- CHIC-3
- Status last verified
- Aug 2014
- First submitted
- 29 Sep 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faysse M, Coscas G, Soubrane G, Souied E. Hemodilution therapy using automated erythrocytapheresis in central retinal vein occlusion: results of a multicenter randomized controlled study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):505-12. doi: 10.1007/s00417-010-1532-5. Epub 2010 Oct 17.
PubMed 20953877
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Efficacy and Tolerance of Intravitreous Injection of Ranibizumab (Lucentis®) in Early-onset Central Retinal Vein Occlusion in Comparison to Hemodilution Using Erythrocytapheresis
- ClinicalTrials.gov ID
- NCT01448018
- Acronym / sponsor ID
- CHIC-3 / 2009-011403-23
- Conditions
- Central Retinal Vein Occlusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Oct 2011 (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 compare ranibizumab injection to hemodilution at the early phase of Central Retinal Vein Occlusion (CRVO) and to determine if the combination of both treatments may have a synergic effect.
Detailed description
Patients with recent-onset CRVO (lasting for less than 1 month)are randomly assigned to one of 3 groups: hemodilution using erythrocytapheresis alone, 3 monthly injection of ranibizumab alone, or both.
Patients are followed monthly during the 6-month study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Active comparator | Drug: ranibizumabpatients in this arm receive 3 monthly injection of ranibizumab |
| Hemodilution | Active comparator | Procedure: hemodilutionhemodilution using erythrocytapheresis is performed as early as possible after inclusion, in order to lessen hematocrit level (target hematocrit of 35%) |
| ranibizumab and hemodilution | Active comparator | Drug: ranibizumab, Procedure: hemodilutionpatients receive both treatments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CRVO confirmed by fluorescein angiography
- duration from onset of 1 month or less
- visual acuity of 20/32 or less
Key exclusion criteria (4 listed)
- neovascular complication
- extensive retinal ischemia requiring prompt panretinal photocoagulation
- hematocrit level lower than 38%
- previous laser or surgery in the study eye, etc
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 |
|---|---|---|
| ranibizumabAlso: Lucentis3 monthly intravitreous injection as soon as possible after the inclusion | Drug | ranibizumab, ranibizumab and hemodilution |
| hemodilutionhemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion | Procedure or surgery | Hemodilution, ranibizumab and hemodilution |
Primary outcome
Change in visual acuity
Time frame: 6 months
Change in best-corrected visual acuity (ETDRS chart) between baseline and 6 months
1 secondary outcome
Gain in visual acuity of 2 ETDRS-lines or more
Time frame: 6 months
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 13 Aug 2014.
- Background: PubMed 20953877Glacet-Bernard A, Atassi M, Fardeau C, Romanet JP, Tonini M, Conrath J, Denis P, Mauget-Faysse M, Coscas G, Soubrane G, Souied E. Hemodilution therapy using automated erythrocytapheresis in central retinal vein occlusion: results of a multicenter randomized controlled study. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):505-12. doi: 10.1007/s00417-010-1532-5. Epub 2010 Oct 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ranibizumab and hemodilution in people with Central Retinal Vein Occlusion, run by Centre Hospitalier Intercommunal Creteil 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 3 inclusion and 4 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 13 Aug 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 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?
Change in visual acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448018, which also lists 1 linked publication.
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 13 Aug 2014; AzTrials last refreshed its copy on 7 Nov 2026.