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Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT (RabOCT)

Primary Purpose

Branch Retinal Vein Occlusion

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Ranibizumab

About this trial

This is an interventional treatment trial for Branch Retinal Vein Occlusion focused on measuring BRVO, Macular edema, Ranibizumab, re-treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Department of Ophthalmology, University Leipzig

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OCT guided group

Standard treatment

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Central retinal thickness (CRT)

Number of applied ranibizumab injections

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

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

Full Information

NCT ID

NCT01968239

First Posted

October 18, 2013

Last Updated

November 30, 2018

Sponsor

University of Leipzig

1. Study Identification

Unique Protocol Identification Number

NCT01968239

Brief Title

Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT

Acronym

RabOCT

Official Title

A Randomized, Controlled Interventional Phase 2b (Proof of Concept) Study of the Efficacy, Safety, and Tolerability of Repeated Intravitreal Administration of Ranibizumab Guided by Morphological Changes Documented by Optical Coherence Tomography (OCT) in Subjects With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

October 2013 (Actual)

Primary Completion Date

June 17, 2016 (Actual)

Study Completion Date

December 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Leipzig

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

In a prospective, randomized, interventional, controlled phase IIb clinical the functional results of treatment with ranibizumab in patients with macular edema due to branch retinal vein occlusion when given according to morphological changes detected by OCT compared to standard re-treatment criteria according to SmPC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Branch Retinal Vein Occlusion

Keywords

BRVO, Macular edema, Ranibizumab, re-treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OCT guided group

Arm Type

Experimental

Arm Description

Arm Title

Standard treatment

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Ranibizumab

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Central retinal thickness (CRT)

Time Frame

12 months

Title

Number of applied ranibizumab injections

Time Frame

12 months

Title

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

Time Frame

12 months

Title

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

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matus Rehak, MD, Ph.D.

Organizational Affiliation

Department of Ophthalmology, University of Leipzig, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Ophthalmology, University Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

12. IPD Sharing Statement

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Proof of Concept Study of Re-treatment in BRVO With Ranibizumab Guided by OCT

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