NCT01875770

Brief Summary

This research is being done to assess the long term prognosis of patients treated with ranibizumab for edema due to retinal vein occlusion.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
Last Updated

October 12, 2021

Status Verified

May 1, 2021

Enrollment Period

5.8 years

First QC Date

June 10, 2013

Last Update Submit

October 8, 2021

Conditions

Keywords

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in BCVA at 5 and 10 years.

    Mean change from baseline in BCVA at 5 and 10 years.

    10 years

Secondary Outcomes (1)

  • Mean change from baseline in foveal thickness at 5 and 10 years

    10 years

Study Arms (1)

Treated with Ranibizumab in previous trial

Treated with Ranibizumab in previous trial

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who have been enrolled in the following three trials will be included in the study: A) "A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects with Macular Edema Secondary to Vein Occlusions.", B) "Extended follow-up of patients with macular edema due to bRanch rETinal vein occlusion (BRVO) or centrAl retinal veIn occlusioN (CRVO) previously treated with intravitreal ranibizumab (RETAIN) " C) "RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach (RELATE)"

You may qualify if:

  • All patients who have been enrolled in the following three trials will be included in the study:
  • A) "A Pilot, Open-Label Study of the Safety, Tolerability, and Bioactivity of Multiple Intravitreal Injections of Ranibizumab in Subjects with Macular Edema Secondary to Vein Occlusions.", B) "Extended follow-up of patients with macular edema due to bRanch rETinal vein occlusion (BRVO) or centrAl retinal veIn occlusioN (CRVO) previously treated with intravitreal ranibizumab (RETAIN) " C) "RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach (RELATE)"

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Peter Campochiaro, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

January 1, 2013

Primary Completion

October 11, 2018

Study Completion

March 3, 2021

Last Updated

October 12, 2021

Record last verified: 2021-05

Locations