Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

Macular Edema Clinical Trial

— RABAMES  

Official title:

Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562406
• Other study ID #: AU-06104G
• Status: Completed
• Phase: N/A
• First received: November 21, 2007
• Last updated: July 20, 2011
• Start date: November 2007
• Est. completion date: September 2010

Study information

• Verified date: July 2011
• Source: Klinikum Ludwigshafen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab
intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8

Procedure:
• Laser photocoagulation
laser photocoagulation to the retina at the area of edema

Locations

Country	Name	City	State
Germany	RABAMES investigational trial site	Freiburg
Germany	RABAMES investigational trial site	Göttingen
Germany	RABAMES investigational trial site	Ludwigshafen
Germany	RABAMES investigational trial site	Mainz

Sponsors (3)

Lead Sponsor	Collaborator
Klinikum Ludwigshafen	Coordination center for clinical studies, Mainz, Germany, Norvartis Pharma, Nuremberg, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in best spectacle-corrected visual acuity (BSCVA)		from baseline to month 6
Secondary	Mean change in BSCVA		from baseline to month 3
Secondary	Proportion of patients who gain = 5, 10, 15 letters of BSCVA		from baseline to month 3 and 6
Secondary	Proportion of patients who lose less than 15 letters of BCVA		from baseline to month 3 and 6
Secondary	Change in area and intensity of leakage		from baseline to month 1, 3 and 6
Secondary	Mean change in central macular thickness (by OCT)		from baseline to month 1, 3 and 6
Secondary	Mean change in central macular thickness (by OCT)		from month 3 to 6