Macular EdemaRABAMESNCT00562406
Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
A study testing Ranibizumab and Laser photocoagulation in people with Macular Edema, run by Klinikum Ludwigshafen at 4 sites in Germany.
Trial summary
The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Ranibizumab and Laser photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesGermany
- Study dates
- Nov 2007to Sep 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older with chronic (> 3months, < 18 months) macular edema secondary to branch retinal vein occlusion
- Patients who at baseline have a BSCVA in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters
- Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by fluorescein angiography:
- Evidence that the macular edema extends under the geometric center of the foveal avascular zone.
- Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e.g. uveitis).
- Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by optical coherence tomography (OCT 3):
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- Evidence that central macular thickness is > 225 μm.
- Ability of subject to understand character and individual consequences of clinical trial.
- Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
- For women with childbearing potential, adequate contraception (negative pregnancy test result, serum or urine at trial entry, after treatment and at end of study).
- Only one eye of a patient may be included to this trial.
Who cannot join
- Patients who at baseline
- Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age-related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others)
- Have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies)
- Had previous treatment for macular edema (laser, triamcinolone, vitrectomy)
- Pregnancy and lactation.
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
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- Participation in other clinical trials within the last 3 months.
- Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
- Arterial hypertension refractory to medical treatment
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
RABAMES investigational trial site
Freiburg im Breisgau
RABAMES investigational trial site
Göttingen
RABAMES investigational trial site
Ludwigshafen, 67063
RABAMES investigational trial site
Mainz
About this study
The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.
- Conditions
- Macular Edema
- Being tested
- Ranibizumab, Laser photocoagulation
- Keywords
- Macular edema secondary to branch retinal vein occlusion
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
Laser photocoagulationProcedure or surgery
laser photocoagulation to the retina at the area of edema
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | laser photocoagulation to the retina at the area of edema Receives: Procedure: Laser photocoagulation |
| 2 | Experimental | intravitreal injection of ranibizumab Receives: Drug: Ranibizumab; Procedure: Laser photocoagulation |
| 3 | Experimental | laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in best spectacle-corrected visual acuity (BSCVA)
Measured: from baseline to month 6
Secondary outcomes (6)
Mean change in BSCVA
Measured: from baseline to month 3
Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA
Measured: from baseline to month 3 and 6
Proportion of patients who lose less than 15 letters of BCVA
Measured: from baseline to month 3 and 6
Change in area and intensity of leakage
Measured: from baseline to month 1, 3 and 6
Mean change in central macular thickness (by OCT)
Measured: from baseline to month 1, 3 and 6
Mean change in central macular thickness (by OCT)
Measured: from month 3 to 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionSep 2010
- Study completionSep 2010
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 Macular EdemaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Ludwigshafen
- Sponsor type
- University, hospital or other
- Collaborators
- Norvartis Pharma, Nuremberg, Germany, Coordination center for clinical studies, Mainz, Germany
- Investigators
- Lars-Olof Hattenbach, MD, Privatdozent, Principal investigator, Dept. of Ophthalmology, Ludwigshafen hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562406
- Sponsor's protocol ID
- AU-06104G
- Acronym
- RABAMES
- Status last verified
- Jul 2011
- First submitted
- 21 Nov 2007
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Pielen A, Mirshahi A, Feltgen N, Lorenz K, Korb C, Junker B, Schaefer C, Zwiener I, Hattenbach LO; RABAMES Study Group. Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES): six-month results of a prospective randomized clinical trial. Acta Ophthalmol. 2015 Feb;93(1):e29-37. doi: 10.1111/aos.12488. Epub 2014 Jul 8.
PubMed 25042729
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
- ClinicalTrials.gov ID
- NCT00562406
- Acronym / sponsor ID
- RABAMES / AU-06104G
- Conditions
- Macular Edema
- Keywords
- Macular edema secondary to branch retinal vein occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Klinikum LudwigshafenUniversity, hospital or other
- Collaborators
- Norvartis Pharma, Nuremberg, Germany, Coordination center for clinical studies, Mainz, Germany
- Study start
- Nov 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 22 Nov 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.
The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Laser photocoagulationlaser photocoagulation to the retina at the area of edema |
| 2 | Experimental | Drug: Ranibizumab, Procedure: Laser photocoagulationintravitreal injection of ranibizumab |
| 3 | Experimental | Drug: Ranibizumablaser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults aged 18 years and older with chronic (> 3months, < 18 months) macular edema secondary to branch retinal vein occlusion
- Patients who at baseline have a BSCVA in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters
- Patients who at baseline have a chronic macular edema (> 3 months) in the study eye with the following characteristics as determined by fluorescein angiography:
- Evidence that the macular edema extends under the geometric center of the foveal avascular zone.
- Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e.g. uveitis).
Key exclusion criteria (9 listed)
- Patients who at baseline
- Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age-related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others)
- Have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies)
- Had previous treatment for macular edema (laser, triamcinolone, vitrectomy)
- Pregnancy and lactation.
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: Lucentisintravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8 | Drug | 2, 3 |
| Laser photocoagulationlaser photocoagulation to the retina at the area of edema | Procedure or surgery | 1, 2 |
Primary outcome
Changes in best spectacle-corrected visual acuity (BSCVA)
Time frame: from baseline to month 6
6 secondary outcomes
Mean change in BSCVA
Time frame: from baseline to month 3
Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA
Time frame: from baseline to month 3 and 6
Proportion of patients who lose less than 15 letters of BCVA
Time frame: from baseline to month 3 and 6
Change in area and intensity of leakage
Time frame: from baseline to month 1, 3 and 6
Mean change in central macular thickness (by OCT)
Time frame: from baseline to month 1, 3 and 6
Mean change in central macular thickness (by OCT)
Time frame: from month 3 to 6
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 22 Jul 2011.
- Derived from this study: PubMed 25042729Pielen A, Mirshahi A, Feltgen N, Lorenz K, Korb C, Junker B, Schaefer C, Zwiener I, Hattenbach LO; RABAMES Study Group. Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES): six-month results of a prospective randomized clinical trial. Acta Ophthalmol. 2015 Feb;93(1):e29-37. doi: 10.1111/aos.12488. Epub 2014 Jul 8.
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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.
Lars-Olof Hattenbach, MD, Privatdozent principal investigator
Dept. of Ophthalmology, Ludwigshafen hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranibizumab and Laser photocoagulation in people with Macular Edema, run by Klinikum Ludwigshafen at 4 sites in Germany.
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 11 inclusion and 9 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 22 Jul 2011. 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 Germany. 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?
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?
Changes in best spectacle-corrected visual acuity (BSCVA) (time frame: from baseline to month 6). 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 NCT00562406, 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 22 Jul 2011.