Trial Outcomes & Findings for Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion (NCT NCT01198327)

NCT ID: NCT01198327

Last Updated: 2014-01-13

Results Overview

Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 66 participants
• Primary outcome timeframe: 24 mos
• Results posted on: 2014-01-13

Participant Flow

66 retinal vein occlusion patients from the HORIZON study(NCT01198327)were enrolled from 7 sites for long term follow up. The sites were: Wilmer Eye Institute, Ophthalmic Consultants of Boston, Retina Consultants of New Jersey, Retina Consultants Macula Group,Retina Consultants of Houston, Southeast Retina and Retina Vitreous Associates

Participant milestones

Measure	Ranibizumab as Needed Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
Overall Study STARTED	66
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extended Follow-up of Patients With Macular Edema Due to Retinal Vein Occlusion

Baseline characteristics by cohort

Measure	Ranibizumab as Needed n=66 Participants Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants
Age, Continuous	67.9 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 mos

Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.

Outcome measures

Measure	Ranibizumab as Needed n=66 Participants Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.	Ranibizumab as Needed -BRVO Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
Incidence of Serious Adverse Events.	17 number of serious adverse events	—

SECONDARY outcome

Timeframe: 24 mos from study baseline

Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.

Outcome measures

Measure	Ranibizumab as Needed n=28 Participants Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.	Ranibizumab as Needed -BRVO n=28 Participants Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
Mean Changes in Visual Acuity	14.0 ETDRS letters Standard Deviation 20.9	20.1 ETDRS letters Standard Deviation 17.2

SECONDARY outcome

Timeframe: 24 mos from study baseline

Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).

Outcome measures

Measure	Ranibizumab as Needed n=28 Participants Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.	Ranibizumab as Needed -BRVO n=28 Participants Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
Mean Change in Retinal Thickness	-426.0 microns Standard Deviation 270.1	-236.2 microns Standard Deviation 230.3

Adverse Events

Ranibizumab as Needed

Serious events: 17 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ranibizumab as Needed n=66 participants at risk Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
General disorders Death resulting from pre-existing idiopathic pulmonary fibrosis	1.5% 1/66 • Number of events 1
General disorders Death of unknown cause	1.5% 1/66 • Number of events 1
Cardiac disorders ECG for elective knee surgery showed inverted T waves, patient asymptomatic, admitted for workup	1.5% 1/66 • Number of events 1
Cardiac disorders Mild chest discomfort for 6 mos, coronary angiography showed 2 obstructions	1.5% 1/66 • Number of events 1
Cardiac disorders Tachycardia and went to the emergency department	1.5% 1/66 • Number of events 1
Cardiac disorders Syncope with fall because of arrhythmia	1.5% 1/66 • Number of events 1
General disorders Chronic atrial fibrillation, CVA; bladder cancer identified during hospitalization	1.5% 1/66 • Number of events 1
General disorders Head injury resulting from fall	1.5% 1/66 • Number of events 1
Infections and infestations Urinary tract infection leading to septic shock	1.5% 1/66 • Number of events 1
Infections and infestations Hospitalized for pneumonia	3.0% 2/66 • Number of events 3
Musculoskeletal and connective tissue disorders Hospitalized for elective surgery	3.0% 2/66 • Number of events 3
Eye disorders Vitreous hemorrhage,	1.5% 1/66 • Number of events 1
Eye disorders Second branch retinal vein occlusion in same eye	1.5% 1/66 • Number of events 1
Eye disorders Retinal tear in a patient with branch retinal vein occlusion who did not receive any treatment	1.5% 1/66 • Number of events 1
Eye disorders Severe reaction to povidon-iodine	1.5% 1/66 • Number of events 1

Other adverse events

Measure	Ranibizumab as Needed n=66 participants at risk Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
General disorders Upper Respiratory Infection	30.3% 20/66 • Number of events 26
Eye disorders Ocular discomfort	19.7% 13/66 • Number of events 15
Eye disorders Subconjuctival Hemorrhage	19.7% 13/66 • Number of events 21
Eye disorders Vitreous Hemmorhage	10.6% 7/66 • Number of events 8

Additional Information

Peter Campocahiro

Wilmer Eye Institute

Phone: 410-955-5106

Email: pcampo@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place