Trial Outcomes & Findings for REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study (NCT NCT01247220)

NCT ID: NCT01247220

Last Updated: 2014-10-06

Results Overview

ETDRS visual acuity

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

6 and 12 months

Results posted on

2014-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Peripheral Laser + Ranibizumab Angiography-directed peripheral laser + ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg Peripheral Laser: Angiography-directed peripheral laser	Ranibizumab Ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peripheral Laser + Ranibizumab n=6 Participants Angiography-directed peripheral laser + ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg Peripheral Laser: Angiography-directed peripheral laser	Ranibizumab n=6 Participants Ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg	Total n=12 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 18 • n=5 Participants	70 years STANDARD_DEVIATION 10 • n=7 Participants	69.5 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 and 12 months

ETDRS visual acuity

Outcome measures

Outcome measures
Measure	Peripheral Laser + Ranibizumab n=6 Participants Angiography-directed peripheral laser + ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg Peripheral Laser: Angiography-directed peripheral laser	Ranibizumab n=6 Participants Ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Visual Acuity 6 month results	16.8 letters on ETDRS Visual Acuity Chart Standard Deviation 10.1	14.5 letters on ETDRS Visual Acuity Chart Standard Deviation 11.6
Visual Acuity 12 month results	19.1 letters on ETDRS Visual Acuity Chart Standard Deviation 7.4	15.3 letters on ETDRS Visual Acuity Chart Standard Deviation 13.2

SECONDARY outcome

Timeframe: 12 months

Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in second six months of observation period

Outcome measures

Outcome measures
Measure	Peripheral Laser + Ranibizumab n=6 Participants Angiography-directed peripheral laser + ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg Peripheral Laser: Angiography-directed peripheral laser	Ranibizumab n=6 Participants Ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Number of Ranibizumab Injections	0.06 injections Interval 0.0 to 1.0	2.2 injections Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 6 and 12 months

central foveal thickness on optical coherence tomography

Outcome measures

Outcome measures
Measure	Peripheral Laser + Ranibizumab n=6 Participants Angiography-directed peripheral laser + ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg Peripheral Laser: Angiography-directed peripheral laser	Ranibizumab n=6 Participants Ranibizumab Ranibizumab: Intravitreal Ranibizumab 0.5 mg
Retinal Thickness 6 month results	207 microns Standard Deviation 47	241 microns Standard Deviation 45
Retinal Thickness 12 month results	282 microns Standard Deviation 26	281 microns Standard Deviation 29

Adverse Events

Peripheral Laser + Ranibizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ranibizumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ivan J. Suner, MD

Retina Associates of Florida

Phone: 813-875-6373

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place