Trial Outcomes & Findings for Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD) (NCT NCT00775411)

Results Overview

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 Week 4.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2012-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	700 µg Dexamethasone + Ranibizumab 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
Overall Study STARTED	44
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	700 µg Dexamethasone + Ranibizumab n=44 Participants 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
Age Continuous	72.3 Years STANDARD_DEVIATION 10.43 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Participants from the Intent to treat Population consisting of all enrolled participants with data available at Week 4 for analyses.

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 Week 4.

Outcome measures

Outcome measures
Measure	700 µg Dexamethasone + Ranibizumab n=43 Participants 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 Baseline	360.9 Microns Standard Deviation 69.23
Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 Change from baseline at Week 4	-62.0 Microns Standard Deviation 78.68

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Intent to treat population consisting of all enrolled participants.

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 measures
Measure	700 µg Dexamethasone + Ranibizumab n=44 Participants 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 Baseline	46.5 Number of letters Standard Deviation 17.73
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 Change from baseline at Week 26	4.5 Number of letters Standard Deviation 9.62

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participants from the Intent to treat population consisting of all enrolled participants with data available for analysis at Week 26.

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 at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased \>=10%), Unchanged (Leakage area changed \< 10%) and Worsened (Leakage area increased \>=10%).

Outcome measures

Outcome measures
Measure	700 µg Dexamethasone + Ranibizumab n=43 Participants 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 Improved	74.4 Percentage of participants
Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 Unchanged	18.6 Percentage of participants
Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 Worsened	7.0 Percentage of participants

Adverse Events

700 µg Dexamethasone + Ranibizumab

Serious events: 6 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	700 µg Dexamethasone + Ranibizumab n=44 participants at risk 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
Blood and lymphatic system disorders Anaemia	2.3% 1/44
Cardiac disorders Cardio-respiratory arrest	2.3% 1/44
Cardiac disorders Coronary artery disease	2.3% 1/44
Infections and infestations Endophthalmitis	2.3% 1/44
Injury, poisoning and procedural complications Fall	2.3% 1/44
Infections and infestations Gastroenteritis	2.3% 1/44
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.3% 1/44
Infections and infestations Urinary tract infection	2.3% 1/44

Other adverse events

Other adverse events
Measure	700 µg Dexamethasone + Ranibizumab n=44 participants at risk 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion.
Eye disorders Conjunctival haemorrhage	13.6% 6/44
Investigations Intraocular pressure increased	6.8% 3/44

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