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

Klinikum Ludwigshafen

Status: Completed

Conditions: Macular Edema

Treatments: Procedure: Laser photocoagulation; Drug: Ranibizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00562406

AU-06104G

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

1

Active Comparator group

Description:

laser photocoagulation to the retina at the area of edema

Treatment:

Procedure: Laser photocoagulation

2

Experimental group

Description:

intravitreal injection of ranibizumab

Treatment:

Drug: Ranibizumab

Procedure: Laser photocoagulation

3

Experimental group

Description:

laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab

Treatment:

Drug: Ranibizumab