Trial Outcomes & Findings for Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration (NCT NCT01122511)

Results Overview

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Baseline, Month 12

Results posted on

2012-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamethasone and Ranibizumab Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Ranibizumab and Sham Intravitreal injection of ranibizumab and sham into study eye.
Overall Study STARTED	2	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone and Ranibizumab n=2 Participants Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Ranibizumab and Sham n=2 Participants Intravitreal injection of ranibizumab and sham into study eye.	Total n=4 Participants Total of all reporting groups
Age, Customized Between 50 and 80 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized >=80 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: No participants reached the 12 month time-point. Efficacy analyses were not performed.

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: No participants reached the 12 month time-point. Efficacy analyses were not performed.

BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: No participants reached the 12 month time-point. Efficacy analyses were not performed.

Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Month 12.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: No participants reached the 12 month time-point. Efficacy analyses were not performed.

Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at baseline and Week 12.

Outcome measures

Outcome data not reported

Adverse Events

Dexamethasone and Ranibizumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Ranibizumab and Sham

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexamethasone and Ranibizumab n=2 participants at risk Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Ranibizumab and Sham n=2 participants at risk Intravitreal injection of ranibizumab and sham into study eye.
Gastrointestinal disorders Tooth Disorder	50.0% 1/2 • 6 Months	0.00% 0/2 • 6 Months
Eye disorders Retinal oedema	0.00% 0/2 • 6 Months	50.0% 1/2 • 6 Months

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER