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

• Sponsor: Allergan (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01122511
• Collaborator: (none)
• Enrollment: 4
• Locations: 2
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration

Condition or Disease	Intervention/Treatment	Phase
Subfoveal Choroidal Neovascularization; Age-Related Maculopathy	Drug: 700 ug dexamethasone; Biological: ranibizumab; Other: sham	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 700 ug dexamethasone and ranibizumab Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye	Drug: 700 ug dexamethasone; Intravitreal injection of 700 ug dexamethasone into study eye; Other Names: OZURDEX® ; Biological: ranibizumab; Intravitreal injection of ranibizumab into study eye; Other Names: Lucentis®
Active Comparator: ranibizumab and sham Intravitreal injection of ranibizumab and Sham into study eye	Biological: ranibizumab; Intravitreal injection of ranibizumab into study eye; Other Names: Lucentis® ; Other: sham; Sham needle-less injection administered in the study eye

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 [Baseline, Month 12]

   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.

Secondary Outcome Measures

1. The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12 [Baseline, Month 12]

   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.

2. Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography [Baseline, Month 12]

   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.

3. Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography [Baseline, Month 12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Received at least 2 and no more than 3 monthly Lucentis or Avastin injections

• Last Lucentis or Avastin was injected approximately 4 weeks prior to screening

• Visual acuity between 20/320 and 20/40

Exclusion Criteria:

• Active ocular infection

• Contraindication to pupil dilation in either eye

• Eye surgery including cataract surgery and/or laser of any type within 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fort Myers	Florida	United States
2		Abilene	Texas	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01122511
• Other Study ID Numbers: 206207-021
• First Posted: May 13, 2010
• Last Update Posted: Sep 5, 2012
• Last Verified: Aug 1, 2012

• Additional relevant MeSH terms: Choroidal Neovascularization; Macular Degeneration; Neovascularization, Pathologic; Dexamethasone; Ranibizumab

Study Results

Participant Flow

Arm/Group Title	Dexamethasone and Ranibizumab	Ranibizumab and Sham
Arm/Group Description	Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Intravitreal injection of ranibizumab and sham into study eye.
Period Title: Overall Study
STARTED	2	2
COMPLETED	0	0
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Dexamethasone and Ranibizumab	Ranibizumab and Sham	Total
Arm/Group Description	Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Intravitreal injection of ranibizumab and sham into study eye.	Total of all reporting groups
Overall Participants	2	2	4
Age, Customized (Number) [Number]
Between 50 and 80 years	1 50%	0 0%	1 25%
>=80 years	1 50%	2 100%	3 75%
Sex: Female, Male (Count of Participants)
Female	2 100%	0 0%	2 50%
Male	0 0%	2 100%	2 50%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
Description	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.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dexamethasone and Ranibizumab	Ranibizumab and Sham
Arm/Group Description	Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Intravitreal injection of ranibizumab and sham into study eye.
Measure Participants	0	0

2. Secondary Outcome

Title	The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12
Description	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.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dexamethasone and Ranibizumab	Ranibizumab and Sham
Arm/Group Description	Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Intravitreal injection of ranibizumab and sham into study eye.
Measure Participants	0	0

3. Secondary Outcome

Title	Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography
Description	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.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dexamethasone and Ranibizumab	Ranibizumab and Sham
Arm/Group Description	Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Intravitreal injection of ranibizumab and sham into study eye.
Measure Participants	0	0

4. Secondary Outcome

Title	Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography
Description	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.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Dexamethasone and Ranibizumab	Ranibizumab and Sham
Arm/Group Description	Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.	Intravitreal injection of ranibizumab and sham into study eye.
Measure Participants	0	0

Adverse Events

Time Frame	6 Months
Arm/Group Title	Dexamethasone and Ranibizumab		Ranibizumab and Sham
Arm/Group Description	Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.		Intravitreal injection of ranibizumab and sham into study eye.
All Cause Mortality
	Dexamethasone and Ranibizumab		Ranibizumab and Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dexamethasone and Ranibizumab		Ranibizumab and Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone and Ranibizumab		Ranibizumab and Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		1/2 (50%)
Eye disorders
Retinal oedema	0/2 (0%)		1/2 (50%)
Gastrointestinal disorders
Tooth Disorder	1/2 (50%)		0/2 (0%)

Limitations/Caveats

The study was terminated early due to difficulties with patient recruitment. No participants reached the 12 month time-point. Efficacy analyses were not performed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.