NCT01968239

Brief Summary

The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected by OCT compared to re-treatment according to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of BCVA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2016

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

2.7 years

First QC Date

October 18, 2013

Last Update Submit

November 30, 2018

Conditions

Branch Retinal Vein Occlusion

Keywords

BRVOMacular edemaRanibizumabre-treatment

Outcome Measures

Primary Outcomes (1)

  • change of best corrected visual acuity (BCVA) measured in ETDRS letters

    12 months

Secondary Outcomes (4)

  • Central retinal thickness (CRT)

    12 months

  • Number of applied ranibizumab injections

    12 months

  • • Rates of patients developing a neovascularisation of the retina/ anterior segment

    12 months

  • Assessment of safety: serious adverse events/ reactions; AEs/ARs

    12 months

Study Arms (2)

OCT guided group

EXPERIMENTAL

Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab if the morphological macular changes for recurrence of macular edema (microcystic changes with or without increase of central retinal thickness) will be detected by OCT.

Drug: Ranibizumab

Standard treatment

ACTIVE COMPARATOR

Patients randomized to this group will get the intravitreal injection of 0.5 mg ranibizumab according to the in SmPC defined re-treatment criteria (re-injection if decrease of BCVA will be detected).

Drug: Ranibizumab

Interventions

RanibizumabDRUG

comparison of different re-treatment criteria for intravitreal injection of ranibizumab

OCT guided groupStandard treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recurrence of macular edema defined as any kind of fluid accumulation in the macula (microcystic changes with or without increase of central retinal thickness) detected by OCT in the month 1 to 6 after the last Lucentis injection without any decrease of BCVA measured with ETDRS charts 2. Diagnosis of BRVO with macular edema treated with at least three intravitreally applied injections of ranibizumab after the up-load phase of treatment 3. Age ≥ 18 years 4. Ability and willingness to attend all scheduled visits and assessments 5. For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study

You may not qualify if:

  • Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
  • 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
  • Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) prior to study entry
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months
  • Pregnancy (positive pregnancy test) or lactation
  • History of allergy to humanized antibodies or any component of the ranibizumab formulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University Leipzig

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Matus Rehak, MD, Ph.D.

    Department of Ophthalmology, University of Leipzig, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D

Study Record Dates

First Submitted

October 18, 2013

First Posted

October 23, 2013

Study Start

October 1, 2013

Primary Completion

June 17, 2016

Study Completion

December 20, 2016

Last Updated

December 3, 2018

Record last verified: 2018-11

Locations

DE(1)