Re-treatment with intravitreal application of ranibizumab guided by morphological macular changes documented by optical coherence tomography (OCT) in patients with macular edema due to branch retinal vein occlusio

Phase 1

• Conditions: macular edema secondary to branch retinal vein occlusion (BRVO); MedDRA version: 18.1Level: LLTClassification code 10054467Term: Macular edemaSystem Organ Class: 100000004853; MedDRA version: 18.1Level: LLTClassification code 10038906Term: Retinal vein branch occlusionSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-005439-10-DE
• Lead Sponsor: niversity of Leipzig Ritterstr. 26, 04109 Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-23
• Study Completion: 2016-05-17
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.Completed up-load phase of ranibizumab treatment (at least 3 monthly intravitreal injections) due to macular edema secondary to branch retinal vein occlusion with presence of recurrence of macular edema detected by optical coherence tomography (OCT) without decrease of BCVA score more than 3 ETDRS letters when compared with BCVA on day of 3rd ranibizumab application
2.BCVA score in the study eye between 20 letters (20/400) and 78 letters (20/32) measured in ETDRS chart and foveal thickness = 250 µm (measured by OCT) and prior to the first ranibizumab injection
3.Age = 18 years
4.Written informed consent of the patient
5.The history of BRVO no longer than 8 months prior to the first ranibizumab injection
6.Ability and willingness to attend all scheduled visits and assessments

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

1.Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
2.Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
3.An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
4.Aphakia
5.Macular laser photocoagulation in the study eye prior to study entry
6.Use of intraocular or periocular injection of steroids in the study eye prior to study entry
7.Cataract surgery or Yttrium-Aluminum-Garnet (YAG) laser capsulotomy or any other intraocular surgery in the study eye within 3 months prior to study entry
8.History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months prior to randomization
9.The presence of active malignancy
10.Pregnancy (positive pregnancy test) or lactation
11.History of allergy to humanized antibodies or any component of the ranibizumab formulation
12.Participation in another simultaneous medical investigation or trial
13.Women with child bearing potency without effective contraception (i. e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner) during the conduct of the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified