Central Retinal Vein OcclusionPhase 3NCT00567697
A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO
A Phase 3 study testing ranibizumab in people with Central Retinal Vein Occlusion and Macular Edema, run by Aleris Helse at 4 sites in Norway.
Trial summary
A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Central Retinal Vein Occlusion, Macular Edema
- What is being tested?
- ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesNorway
- Study dates
- Mar 2007to Oct 2008
- Phase
- Phase 3
- 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
- Male and female ≥ 50 years
- Patients who have findings consistent with CRVO
- Patients who have a history of decreased visual acuity ≤ 6 months
- Patients who have a best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73 (4 m distance) or ≥ 6 (1 m distance) using an ETDRS chart
- Patients who have a macular edema verified by OCT
- Patients who have macular edema in the study eye with the following characteristics as determined by fluorescein angiography:
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- secondary to non-iscemic CRVO defined as non-perfusion < 10 DA OR
- secondary to ischemic CRVO defined as non-perfusion > 10 DA
- Willing and able to give written informed consent and who are willing and able to comply with study procedures
- Ability to cooperate with photo and OCT examinations
Who cannot join
- Neovascularisations in the study eye at baseline
- Previous treatment with or participation in a clinical trial (for either eye) involving anti-angiogenics drugs
- Use of other investigational drugs
- Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
- History of submacular surgery in the study eye, glaucoma filtration, corneal transplantation surgery
- Previous or current intravitreal or sub-Tenon drug delivery in the study eye
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- Laserphotocoagulation (juxtafoveal or extrafoveal) in the study eye within one month preceding Baseline
- Extracapsular extraction of cataract with phacoemulcification within three months preceding Baseline, or a history of post-complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis etc)
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)
- Previous violation of the posterior capsule in the study eye unless it occurred as a result of YAG laser posterior capsulotomy in assosiation with prior, posterior chamber lens implantation
- Afakia with absence of the posterior capsule in the study eye
- Active intraocular inflammation in the study eye
- Any active infection involving the ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as ideopathic or autoimmune-associated uveitis in either eye
- Vitreous hemorrhage or history og rhegmatogenous retinal detachment or macular hole in the study eye
- Any current intraocular condition in the study eye (cataract or diabetic retinopathia) that in the opinion of the investigator, could either require medical or surgical intervention during the study period for the next 6 months
- Ocular condition that requires chronic concomitant therapy with systemic or topical ocular corticosteroids.
- Current treatment for active systemic infection.
- Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve.
- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or might affect interpretation of the results of the study or render the subject at high risk for treatment complications
- History of hypersensitivity or allergy to fluorescein
- Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed
- Pregnant or nursing (lactating) women
- Pre-menopausal women of child-bearing potential not using adequate contraception.
- History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrance or metastases.
Trial locations and contacts
4 sites in 1 country.
Norway4 sites
Bettina Kinge, Retinaklinikken Aleris
Oslo, 0264
Ingar Stene Johansen
Oslo
Vegard Forsaa
Stavanger
Kristian Fossen
Tromsø
About this study
Official title: A Randomized Study Comparing the Safty Anf Efficacy of Ranibizumab (Lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO
A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.
- Conditions
- Central Retinal Vein Occlusion, Macular Edema
- Being tested
- ranibizumab
- Keywords
- ranibizumab, CRVO, macular edema, sham
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months.
ranibizumabDrug
Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection Receives: Drug: ranibizumab |
| B | Sham comparator | Not described Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy outcome measure is the mean change from baseline in BCVA score
Measured: 6 months
Secondary outcomes (1)
Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale.
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 posted5 Dec 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aleris Helse
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Bettina Kinge, MD DMSc, Principal investigator, Aleris Helse, Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567697
- Sponsor's protocol ID
- ROCC study 2007
- Status last verified
- Jan 2012
- First submitted
- 3 Dec 2007
- Last updated
- 19 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kinge B, Stordahl PB, Forsaa V, Fossen K, Haugstad M, Helgesen OH, Seland J, Stene-Johansen I. Efficacy of ranibizumab in patients with macular edema secondary to central retinal vein occlusion: results from the sham-controlled ROCC study. Am J Ophthalmol. 2010 Sep;150(3):310-4. doi: 10.1016/j.ajo.2010.03.028. Epub 2010 Jun 29.
PubMed 20591399
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing the Safty Anf Efficacy of Ranibizumab (Lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO
- ClinicalTrials.gov ID
- NCT00567697
- Acronym / sponsor ID
- ROCC study 2007
- Conditions
- Central Retinal Vein Occlusion, Macular Edema
- Keywords
- ranibizumab, CRVO, macular edema, sham
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aleris HelseUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Dec 2007 (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.
A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: ranibizumab0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection |
| B | Sham comparator | Drug: ranibizumab |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female ≥ 50 years
- Patients who have findings consistent with CRVO
- Patients who have a history of decreased visual acuity ≤ 6 months
- Patients who have a best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73 (4 m distance) or ≥ 6 (1 m distance) using an ETDRS chart
- Patients who have a macular edema verified by OCT
Key exclusion criteria (24 listed)
- Neovascularisations in the study eye at baseline
- Previous treatment with or participation in a clinical trial (for either eye) involving anti-angiogenics drugs
- Use of other investigational drugs
- Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal laser photocoagulation, vitrectomy, or transpupillary thermotherapy.
- History of submacular surgery in the study eye, glaucoma filtration, corneal transplantation surgery
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 |
|---|---|---|
| ranibizumab0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months. | Drug | A |
| ranibizumabSham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema. | Drug | B |
Primary outcome
The primary efficacy outcome measure is the mean change from baseline in BCVA score
Time frame: 6 months
1 secondary outcome
Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale.
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 19 Jan 2012.
- Derived from this study: PubMed 20591399Kinge B, Stordahl PB, Forsaa V, Fossen K, Haugstad M, Helgesen OH, Seland J, Stene-Johansen I. Efficacy of ranibizumab in patients with macular edema secondary to central retinal vein occlusion: results from the sham-controlled ROCC study. Am J Ophthalmol. 2010 Sep;150(3):310-4. doi: 10.1016/j.ajo.2010.03.028. Epub 2010 Jun 29.
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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.
Bettina Kinge, MD DMSc principal investigator
Aleris Helse, Oslo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ranibizumab in people with Central Retinal Vein Occlusion and Macular Edema, run by Aleris Helse at 4 sites in Norway.
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 10 inclusion and 24 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 19 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Norway. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The primary efficacy outcome measure is the mean change from baseline in BCVA score (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 NCT00567697, 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 19 Jan 2012.