A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02181517
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: abicipar pegol; Drug: ranibizumab; Other: sham procedure	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2014
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: abicipar pegol 1 mg Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Drug: abicipar pegol; Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.; Other: sham procedure; Sham procedure to the study eye at weeks 12 and 16.
Experimental: abicipar pegol 2 mg Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Drug: abicipar pegol; Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.; Other: sham procedure; Sham procedure to the study eye at weeks 12 and 16.
Active Comparator: ranibizumab 0.5 mg Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.	Drug: ranibizumab; Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.; Other Names: Lucentis®

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale [Baseline, Week 16]

   BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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. Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale [Baseline, Week 20]

   BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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. Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale [Baseline, Week 20]

   BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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.

3. Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale [Baseline, Week 20]

   BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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.

4. Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye [Baseline, Week 16, Week 20]

   CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosis of wet age-related macular degeneration in at least 1 eye

• Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye

Exclusion Criteria:

• Hypersensitivity, allergy, or anaphylactic reaction to iodine

• Cataract or refractive surgery within the last 3 months

• History of vitrectomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	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: NCT02181517
• Other Study ID Numbers: 150998-003; CYPRESS
• First Posted: Jul 4, 2014
• Last Update Posted: May 17, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Macular Degeneration; Ranibizumab

Study Results

Participant Flow

Arm/Group Title	Abicipar Pegol 1 mg	Abicipar Pegol 2 mg	Ranibizumab 0.5 mg
Arm/Group Description	Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Period Title: Overall Study
STARTED	10	10	5
COMPLETED	10	10	5
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Abicipar Pegol 1 mg	Abicipar Pegol 2 mg	Ranibizumab 0.5 mg	Total
Arm/Group Description	Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.	Total of all reporting groups
Overall Participants	10	10	5	25
Age, Customized (participants) [Number]
≤ 65 years	0 0%	0 0%	0 0%	0 0%
> 65 years	10 100%	10 100%	5 100%	25 100%
Sex: Female, Male (Count of Participants)
Female	9 90%	7 70%	4 80%	20 80%
Male	1 10%	3 30%	1 20%	5 20%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Description	BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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, Week 16

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT) population included all randomized and treated participants with at least 1 follow-up visit.

Arm/Group Title	Abicipar Pegol 1 mg	Abicipar Pegol 2 mg	Ranibizumab 0.5 mg
Arm/Group Description	Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Measure Participants	10	10	5
Baseline	55.2 (12.97)	59.0 (10.36)	57.6 (17.04)
Change from Baseline at Week 16	4.4 (8.96)	10.1 (10.5)	15.2 (6.72)

2. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale
Description	BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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, Week 20

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least 1 follow-up visit.

Arm/Group Title	Abicipar Pegol 1 mg	Abicipar Pegol 2 mg	Ranibizumab 0.5 mg
Arm/Group Description	Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Measure Participants	10	10	5
Baseline	55.2 (12.97)	59.0 (10.36)	57.6 (17.04)
Change from Baseline at Week 20	5.6 (12.12)	6.7 (15.98)	14.4 (7.89)

3. Secondary Outcome

Title	Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale
Description	BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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, Week 20

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least 1 follow-up visit.

Arm/Group Title	Abicipar Pegol 1 mg	Abicipar Pegol 2 mg	Ranibizumab 0.5 mg
Arm/Group Description	Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Measure Participants	10	10	5
Number [percentage of participants]	30.0 300%	30.0 300%	60.0 1200%

4. Secondary Outcome

Title	Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale
Description	BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. 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, Week 20

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least 1 follow-up visit.

Arm/Group Title	Abicipar Pegol 1 mg	Abicipar Pegol 2 mg	Ranibizumab 0.5 mg
Arm/Group Description	Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Measure Participants	10	10	5
Number [percentage of participants]	40.0 400%	40.0 400%	60.0 1200%

5. Secondary Outcome

Title	Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Description	CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Time Frame	Baseline, Week 16, Week 20

Outcome Measure Data

Analysis Population Description

mITT population included all randomized and treated participants with at least 1 follow-up visit.

Arm/Group Title	Abicipar Pegol 1 mg	Abicipar Pegol 2 mg	Ranibizumab 0.5 mg
Arm/Group Description	Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.	Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Measure Participants	10	10	5
Baseline	443.8 (107.32)	383.8 (146.90)	348.8 (33.26)
Change from Baseline at Week 16	-106.5 (128.50)	-112.8 (169.75)	-124.4 (49.51)
Change from Baseline at Week 20	-78.2 (104.73)	-90.3 (178.22)	-110.4 (45.87)

Adverse Events

Arm/Group Title	Abicipar Pegol 1 mg		Abicipar Pegol 2 mg		Ranibizumab 0.5 mg
Arm/Group Description	Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.		Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.		Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
All Cause Mortality
	Abicipar Pegol 1 mg		Abicipar Pegol 2 mg		Ranibizumab 0.5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Abicipar Pegol 1 mg		Abicipar Pegol 2 mg		Ranibizumab 0.5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		1/10 (10%)		0/5 (0%)
Infections and infestations
Pneumonia	0/10 (0%)		1/10 (10%)		0/5 (0%)
Escherichia bacteremia	0/10 (0%)		1/10 (10%)		0/5 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/10 (10%)		0/10 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Abicipar Pegol 1 mg		Abicipar Pegol 2 mg		Ranibizumab 0.5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/10 (50%)		6/10 (60%)		2/5 (40%)
Cardiac disorders
Tricuspid valve incompetence	0/10 (0%)		0/10 (0%)		1/5 (20%)
Eye disorders
Dry eye	1/10 (10%)		1/10 (10%)		0/5 (0%)
Eye pain	0/10 (0%)		1/10 (10%)		1/5 (20%)
Retinal vein occlusion	0/10 (0%)		1/10 (10%)		0/5 (0%)
Uveitis	0/10 (0%)		1/10 (10%)		0/5 (0%)
Vitritis	0/10 (0%)		1/10 (10%)		0/5 (0%)
Iridocyclitis	1/10 (10%)		0/10 (0%)		0/5 (0%)
Punctate keratitis	1/10 (10%)		0/10 (0%)		0/5 (0%)
Retinal haemorrhage	1/10 (10%)		0/10 (0%)		0/5 (0%)
Visual acuity reduced	1/10 (10%)		0/10 (0%)		0/5 (0%)
Conjunctival haemorrhage	0/10 (0%)		0/10 (0%)		1/5 (20%)
General disorders
Oedema peripheral	0/10 (0%)		1/10 (10%)		1/5 (20%)
Immune system disorders
Drug hypersensitivity	0/10 (0%)		1/10 (10%)		0/5 (0%)
Infections and infestations
Influenza	0/10 (0%)		1/10 (10%)		0/5 (0%)
Upper respiratory tract infection	1/10 (10%)		0/10 (0%)		0/5 (0%)
Urinary tract infection	1/10 (10%)		0/10 (0%)		0/5 (0%)
Injury, poisoning and procedural complications
Corneal abrasion	0/10 (0%)		0/10 (0%)		1/5 (20%)
Investigations
Liver function test abnormal	0/10 (0%)		1/10 (10%)		0/5 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension	0/10 (0%)		0/10 (0%)		1/5 (20%)
Vascular disorders
Aortic stenosis	0/10 (0%)		0/10 (0%)		1/5 (20%)

Limitations/Caveats

[Not Specified]

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.