Trial Outcomes & Findings for Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab (NCT NCT01292798)

Results Overview

To determine the mean change in the best-corrected visual acuity on an ETDRS visual acuity chart at a starting distance of 4 meters from baseline to 6 months.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

43 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2016-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	2.0 mg Ranibizumab Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
Overall Study STARTED	43
Overall Study Persistent DME After 3 Months	29
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ranibizumab 0.5mg and 2.0mg to Treat Diabetic Macular Edema in Patients With Poor Response to Bevacizumab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2.0 mg Ranibizumab n=43 Participants Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
Age, Continuous	64.0 years STANDARD_DEVIATION 10.1 • n=93 Participants
Sex: Female, Male Female	20 Participants n=93 Participants
Sex: Female, Male Male	23 Participants n=93 Participants
Region of Enrollment United States	43 participants n=93 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

To determine the mean change in the best-corrected visual acuity on an ETDRS visual acuity chart at a starting distance of 4 meters from baseline to 6 months.

Outcome measures

Outcome measures
Measure	0.5mg and 2.0mgRanibizumab n=43 Participants Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met. Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally
Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline Baseline	58.8 letters Standard Deviation 9.7
Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline 6 months	67.6 letters Standard Deviation 9.3
Overall Mean Change in Visual Acuity Scores at Month 6 Compared to Baseline Change from Baseline to 6 months	8.8 letters Standard Deviation 9.3

SECONDARY outcome

Timeframe: baseline and 6 months

To determine the mean change in central 1-mm subfield thickness as measured by spectral-domain OCT from baseline to 6 months .

Outcome measures

Outcome measures
Measure	0.5mg and 2.0mgRanibizumab n=43 Participants Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met. Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally
Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline Baseline	500.6 microns Standard Deviation 129.1
Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline 6 months	335.2 microns Standard Deviation 91.5
Mean Change in 1-mm Central Subfield (CST) Thickness as Measured by OCT at Month 6 Compared to Baseline Change from Baseline to 6 months	-165.4 microns Standard Deviation 91.5

SECONDARY outcome

Timeframe: Baeline and 6 months

Population: At 6 months, 18 out of the 43 subjects (42%) showed complete resolution of DME. 25 out of the 43 subjects (58%) showed partial or no resolution of DME at 6 months.

To compare the percentage of subjects with compete or partial/no resolution of diabetic macular edema in response to the ranibizumab 0.5 and 2.0 mg doses.

Outcome measures

Outcome measures
Measure	0.5mg and 2.0mgRanibizumab n=43 Participants Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met. Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally
Qualitative Assessment of Diabetic Macular Edema (DME) complete resolution	42 percentage of participants
Qualitative Assessment of Diabetic Macular Edema (DME) partial/no resolution	58 percentage of participants

Adverse Events

2.0 mg Ranibizumab

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2.0 mg Ranibizumab n=43 participants at risk Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
Respiratory, thoracic and mediastinal disorders Acute hypoxic respiratory failure	2.3% 1/43 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Director of Research

California Retina Consultants

Phone: 8059631648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place