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

NCT00562406 | Completed

• 1 other identifier: AU-06104G
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Macular Edema

Keywords

Macular edema secondary to branch retinal vein occlusion

Outcome Measures

Primary Outcomes (1)

• Changes in best spectacle-corrected visual acuity (BSCVA)

  from baseline to month 6

Secondary Outcomes (6)

• Mean change in BSCVA

  from baseline to month 3

• Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA

  from baseline to month 3 and 6

• Proportion of patients who lose less than 15 letters of BCVA

  from baseline to month 3 and 6

• Change in area and intensity of leakage

  from baseline to month 1, 3 and 6

• Mean change in central macular thickness (by OCT)

  from baseline to month 1, 3 and 6

Study Arms (3)

1

ACTIVE COMPARATOR

laser photocoagulation to the retina at the area of edema

Procedure: Laser photocoagulation

2

EXPERIMENTAL

intravitreal injection of ranibizumab

Drug: Ranibizumab; Procedure: Laser photocoagulation

3

EXPERIMENTAL

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

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8

Also known as: Lucentis

2; 3

Laser photocoagulation PROCEDURE

laser photocoagulation to the retina at the area of edema

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Ludwigshafen: lead
• Norvartis Pharma, Nuremberg, Germany: collaborator
• Coordination center for clinical studies, Mainz, Germany: collaborator

Study Sites (4)

RABAMES investigational trial site

Freiburg im Breisgau, Germany

Location

RABAMES investigational trial site

Göttingen, Germany

Location

RABAMES investigational trial site

Ludwigshafen, 67063, Germany

Location

RABAMES investigational trial site

Mainz, Germany

Location

Related Publications (1)

• 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.

  PMID: 25042729 DERIVED

MeSH Terms

Conditions

Macular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lars-Olof Hattenbach, MD, Privatdozent

  Dept. of Ophthalmology, Ludwigshafen hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 22, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

DE (4)