Clinical trial NCT00562406: Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
Official title: Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Edema
Keywords: Macular edema secondary to branch retinal vein occlusion
Lead sponsor: Klinikum Ludwigshafen
Sponsor class: OTHER
Collaborators: name: Norvartis Pharma, Nuremberg, Germany
name: Coordination center for clinical studies, Mainz, Germany
First posted: 2007-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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):
* 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.

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Changes in best spectacle-corrected visual acuity (BSCVA)
timeFrame: from baseline to month 6
Secondary outcomes:
measure: Mean change in BSCVA
timeFrame: from baseline to month 3
measure: Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA
timeFrame: from baseline to month 3 and 6
measure: Proportion of patients who lose less than 15 letters of BCVA
timeFrame: from baseline to month 3 and 6
measure: Change in area and intensity of leakage
timeFrame: from baseline to month 1, 3 and 6
measure: Mean change in central macular thickness (by OCT)
timeFrame: from baseline to month 1, 3 and 6
measure: Mean change in central macular thickness (by OCT)
timeFrame: from month 3 to 6
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: RABAMES investigational trial site
city: Göttingen
country: Germany
facility: RABAMES investigational trial site
city: Ludwigshafen
country: Germany
facility: RABAMES investigational trial site
city: Mainz
country: Germany
facility: RABAMES investigational trial site
Study officials:
affiliation: Dept. of Ophthalmology, Ludwigshafen hospital
name: Lars-Olof Hattenbach, MD, Privatdozent
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.