A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02288559
• Collaborator: (none)
• Enrollment: 96
• Locations: 36
• Arms: 4
• Actual Duration (Months): 26.1
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.

Condition or Disease	Intervention/Treatment	Phase
Geographic Atrophy	Other: Sham; Drug: Lampalizumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy
• Actual Study Start Date: Mar 30, 2015
• Actual Primary Completion Date: Jun 2, 2017
• Actual Study Completion Date: Jun 2, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lampalizumab: Open-label Safety Run-In Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.	Drug: Lampalizumab; 10 mg dose of lampalizumab administered intravitreally
Experimental: Q2W Lampalizumab: Randomized Treatment Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.	Drug: Lampalizumab; 10 mg dose of lampalizumab administered intravitreally
Experimental: Q4W Lampalizumab: Randomized Treatment Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.	Drug: Lampalizumab; 10 mg dose of lampalizumab administered intravitreally
Sham Comparator: Sham: Randomized Treatment Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.	Other: Sham; Sham injection will be administered as a matching intravitreal injection of lampalizumab.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24 [Baseline, Week 24]

   GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.

Secondary Outcome Measures

1. Serum Concentrations of Lampalizumab (Q2W) [Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose]

   Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).

2. Serum Concentrations of Lampalizumab (Q4W) [Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination]

   LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).

3. Percentage of Participants With Ocular Adverse Events (AEs) [Baseline up to approximately 30 weeks]

   An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.

4. Percentage of Participants With Systemic (Non-ocular) Adverse Events [Baseline up to approximately 30 weeks]

   An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.

5. Percentage of Participants With Anti-Lampalizumab Antibodies [Baseline up to approximately 30 weeks]

   Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Complement Factor I (CFI) profile biomarker-positive result

• Women of child bearing potential and men should remain abstinent or use contraceptive methods

Exclusion Criteria:

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye

• Previous subfoveal focal laser photocoagulation in study eye

• Laser photocoagulation in the study eye

• Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye

• Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted

• Previous cell-based intraocular treatment in study eye

• Intraocular surgery in study eye

• Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye

• History of corneal transplant in study eye

• GA in either eye due to causes other than AMD

• Proliferative diabetic retinopathy in either eye

• Active or history of neovascular (wet) AMD in either eye

• History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease

• Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis

• Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle

• Previous expression vector mediated intraocular treatments

• Uncontrolled blood pressure and atrial fibrillation

• Medical conditions associated with clinically significant risk for bleeding-

• Predisposition or history of increased risk for infection

• Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (>/=) 12 months

• History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection

• Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment

• Previous participation in other studies of investigational drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnet Dulaney Perkins Eye Center	Mesa	Arizona	United States	85206
2	University of Arizona; Banner University Medical, Department of Opthalmology	Tucson	Arizona	United States	85711
3	Northwest Arkansas Retina Associates	Springdale	Arkansas	United States	72764
4	Retinal Diagnostic Center	Campbell	California	United States	95008
5	The Retina Partners	Encino	California	United States	91436
6	Loma Linda University	Loma Linda	California	United States	92354
7	San Diego Retina Associates	Oceanside	California	United States	92056
8	West Coast Retina Medical Group	San Francisco	California	United States	94109
9	California Retina Consultants	Santa Barbara	California	United States	93103
10	Colorado Retina Associates, PC	Golden	Colorado	United States	80401
11	Florida Eye Microsurgical Inst	Boynton Beach	Florida	United States	33426
12	National Ophthalmic Research Institute	Fort Myers	Florida	United States	33912
13	Florida Eye Associates	Melbourne	Florida	United States	32901
14	Retina Care Specialists	Palm Beach Gardens	Florida	United States	33410
15	Retina Specialty Institute	Pensacola	Florida	United States	32503
16	Rush University Medical Center	Chicago	Illinois	United States	60612
17	Wolfe Eye Clinic	West Des Moines	Iowa	United States	50266
18	Elman Retina Group	Baltimore	Maryland	United States	21237
19	Vitreoretinal Surgery	Edina	Minnesota	United States	55435
20	The Retina Institute	Saint Louis	Missouri	United States	63128
21	Sierra Eye Associates	Reno	Nevada	United States	89502
22	Eye Associates of New Mexico	Albuquerque	New Mexico	United States	87102
23	Western Carolina Retinal Associate PA	Asheville	North Carolina	United States	28803
24	Char Eye Ear &Throat Assoc	Charlotte	North Carolina	United States	28210
25	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
26	Retina Assoc of Cleveland Inc	Cleveland	Ohio	United States	44122
27	Dean McGee Eye Institute	Oklahoma City	Oklahoma	United States	73099
28	Retina Cons of Charleston	Charleston	South Carolina	United States	29414
29	Carolina Retina Center PA	Columbia	South Carolina	United States	29223
30	Charles Retina Institution	Germantown	Tennessee	United States	38138
31	Southeastern Retina Associates	Knoxville	Tennessee	United States	37923
32	Tennessee Retina PC.	Nashville	Tennessee	United States	37203
33	W Texas Retina Consultants PA	Abilene	Texas	United States	79606
34	Texas Retina Associates	Dallas	Texas	United States	75231
35	Retina Specialists	DeSoto	Texas	United States	75115
36	Wagner Macula & Retina Center	Norfolk	Virginia	United States	23451

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 24, 2015

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT02288559
• Other Study ID Numbers: GX29455
• First Posted: Nov 11, 2014
• Last Update Posted: Sep 25, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Geographic Atrophy; Atrophy

Study Results

Participant Flow

Pre-assignment Detail	A total of 332 participants were screened and 92 participants were randomized out of which 3 participants from one site were removed from the randomized population due to serious good clinical practice (GCP) noncompliance. Out of 89, 4 participants were excluded from the randomized population as they did not have any post-baseline measurement. .

Arm/Group Title	Sham Q2W	Sham Q4W	Lampalizumab Q2W	Lampalizumab Q4W
Arm/Group Description	Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.	Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.	Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.	Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Period Title: Overall Study
STARTED	10	11	46	22
COMPLETED	9	10	35	20
NOT COMPLETED	1	1	11	2

Baseline Characteristics

Arm/Group Title	Sham Q2W	Sham Q4W	Lampalizumab Q2W	Lampalizumab Q4W	Total
Arm/Group Description	Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.	Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.	Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.	Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.	Total of all reporting groups
Overall Participants	10	10	43	22	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.4 (4.4)	78.2 (7.7)	78.3 (8.0)	80.1 (7.7)	78.2 (7.7)
Sex: Female, Male (Count of Participants)
Female	7 70%	8 80%	25 58.1%	9 40.9%	49 57.6%
Male	3 30%	2 20%	18 41.9%	13 59.1%	36 42.4%
Race/Ethnicity, Customized (Count of Participants)
Hispanic or Latino	0 0%	0 0%	1 2.3%	0 0%	1 1.2%
Not Hispanic or Latino	10 100%	10 100%	42 97.7%	22 100%	84 98.8%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	1 10%	0 0%	0 0%	1 1.2%
Asian	1 10%	0 0%	1 2.3%	0 0%	2 2.4%
White	9 90%	9 90%	42 97.7%	22 100%	82 96.5%
Geographic Atrophy Area, as Assessed by Fundus Autofluorescence (FAF) (millimeter square (mm^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [millimeter square (mm^2)]	7.034 (2.747)	6.891 (3.050)	8.755 (4.059)	7.172 (4.192)	7.923 (3.894)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24
Description	GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

Modified intent-to-treat (mITT) population included participants who were randomly assigned to study treatment and had at least one post-baseline GA area measurement. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Sham Q2W	Sham Q4W	Lampalizumab Q2W	Lampalizumab Q4W
Arm/Group Description	Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.	Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.	Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.	Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Measure Participants	10	10	43	22
Mean (Standard Error) [mm^2]	0.614 (0.188)	1.121 (0.179)	1.049 (0.094)	0.911 (0.123)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sham Q2W, Lampalizumab Q2W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0428
	Comments
	Method	Mixed-Effect Model Repeated Measures
	Comments	MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.
Method of Estimation	Estimation Parameter	Difference in Adjusted Means
	Estimated Value	0.435
	Confidence Interval	(2-Sided) 80%; 0.162 to 0.707
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sham Q4W, Lampalizumab Q4W
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3361
	Comments
	Method	MMRM
	Comments	MMRM analysis variables: treatment group, visit, treatment-by-visit interaction, baseline GA area, and BCVA ETDRS chart Snellen equivalent category.
Method of Estimation	Estimation Parameter	Difference in Adjusted Means
	Estimated Value	-0.210
	Confidence Interval	(2-Sided) 80%; -0.491 to 0.071
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Serum Concentrations of Lampalizumab (Q2W)
Description	Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).
Time Frame	Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose

Outcome Measure Data

Analysis Population Description

Pharmacokinetics (PK) population included participants randomized to lampalizumab treatment who received at least one dose of study drug and provided at least one serum sample for determination of lampalizumab. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Lampalizumab Q2W
Arm/Group Description	Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.
Measure Participants	46
Day 1 (Predose)	NA (NA)
Day 1 (Postdose)	1.31 (NA)
Week 2	55.5 (89.1)
Week 4	63.6 (69.4)
Week 8	64.4 (83.7)
Week 16	78.2 (68.0)
Week 24	62.7 (141.4)
Early Termination	4.92 (1070.9)
Unscheduled predose	0.500 (NA)
Unscheduled postdose	0.500 (NA)

3. Secondary Outcome

Title	Serum Concentrations of Lampalizumab (Q4W)
Description	LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).
Time Frame	Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination

Outcome Measure Data

Analysis Population Description

PK population included participants randomized to lampalizumab treatment who received at least one dose of study drug and provided at least one serum sample for determination of lampalizumab. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Lampalizumab Q4W
Arm/Group Description	Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Measure Participants	23
Day 1 (Predose)	NA (NA)
Day 1 (Postdose)	2.08 (NA)
Week 4	8.52 (114.3)
Week 8	10.3 (84.1)
Week 16	8.66 (88.0)
Week 24	9.92 (102.0)
Early Termination	14.1 (NA)

4. Secondary Outcome

Title	Percentage of Participants With Ocular Adverse Events (AEs)
Description	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Time Frame	Baseline up to approximately 30 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis population included all randomized participants who received at least one dose of study drug.

Arm/Group Title	Sham Q2W	Sham Q4W	Lampalizumab Q2W	Lampalizumab Q4W
Arm/Group Description	Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.	Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.	Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.	Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Measure Participants	10	11	46	22
Number [percentage of participants]	60.0 600%	9.1 91%	63.0 146.5%	63.6 289.1%

5. Secondary Outcome

Title	Percentage of Participants With Systemic (Non-ocular) Adverse Events
Description	An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.
Time Frame	Baseline up to approximately 30 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis population included all randomized participants who received at least one dose of study drug.

Arm/Group Title	Sham Q2W	Sham Q4W	Lampalizumab Q2W	Lampalizumab Q4W
Arm/Group Description	Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.	Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.	Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.	Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Measure Participants	10	11	46	22
Number [percentage of participants]	40.0 400%	63.6 636%	52.2 121.4%	50.0 227.3%

6. Secondary Outcome

Title	Percentage of Participants With Anti-Lampalizumab Antibodies
Description	Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.
Time Frame	Baseline up to approximately 30 weeks

Outcome Measure Data

Analysis Population Description

Safety analysis population included all randomized participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Sham Q2W	Sham Q4W	Lampalizumab Q2W	Lampalizumab Q4W
Arm/Group Description	Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.	Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.	Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.	Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.
Measure Participants	10	11	46	22
Treatment-induced ADA	0 0%	0 0%	1 2.3%	1 4.5%
Treatment-enhanced ADA	0 0%	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Baseline up to approximately 30 weeks
Adverse Event Reporting Description	Safety analysis population included all randomized participants who received at least one dose of study drug.
Arm/Group Title	Lampalizumab Q2W		Lampalizumab Q4W		Sham Q2W		Sham Q4W
Arm/Group Description	Participants received 10 milligrams (mg) dose of lampalizumab administered by intravitreal injections Q2W for 24 weeks.		Participants received 10 mg dose of lampalizumab administered by intravitreal injections Q4W for 24 weeks.		Participants received sham comparator Q2W (once every 2 weeks) for 24 weeks.		Participants received sham comparator Q4W (once every 4 weeks) for 24 weeks.
All Cause Mortality
	Lampalizumab Q2W		Lampalizumab Q4W		Sham Q2W		Sham Q4W
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/46 (4.3%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Serious Adverse Events
	Lampalizumab Q2W		Lampalizumab Q4W		Sham Q2W		Sham Q4W
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/46 (15.2%)		3/22 (13.6%)		0/10 (0%)		1/11 (9.1%)
Cardiac disorders
Cardiac arrest	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Myocardial infarction	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Postural orthostatic tachycardia syndrome	0/46 (0%)		1/22 (4.5%)		0/10 (0%)		0/11 (0%)
Eye disorders
Scleritis	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Uveitis	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Gastrointestinal disorders
Abdominal hernia	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Infections and infestations
Influenza	0/46 (0%)		1/22 (4.5%)		0/10 (0%)		0/11 (0%)
Injury, poisoning and procedural complications
Fall	1/46 (2.2%)		1/22 (4.5%)		0/10 (0%)		0/11 (0%)
Femoral neck fracture	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Non-hodgkins lymphoma recurrent	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Nervous system disorders
Embolic stroke	0/46 (0%)		1/22 (4.5%)		0/10 (0%)		0/11 (0%)
Presyncope	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Other (Not Including Serious) Adverse Events
	Lampalizumab Q2W		Lampalizumab Q4W		Sham Q2W		Sham Q4W
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/46 (45.7%)		13/22 (59.1%)		7/10 (70%)		7/11 (63.6%)
Cardiac disorders
Atrial fibrillation	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Ear and labyrinth disorders
Deafness unilateral	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Middle ear effusion	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Vertigo	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Eye disorders
Conjunctival haemorrhage	12/46 (26.1%)		6/22 (27.3%)		3/10 (30%)		1/11 (9.1%)
Eye pain	6/46 (13%)		3/22 (13.6%)		0/10 (0%)		0/11 (0%)
Vitreous floaters	3/46 (6.5%)		2/22 (9.1%)		1/10 (10%)		0/11 (0%)
Vitreous detachment	2/46 (4.3%)		3/22 (13.6%)		0/10 (0%)		0/11 (0%)
Cataract subcapsular	1/46 (2.2%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Photopsia	1/46 (2.2%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Posterior capsule opacification	1/46 (2.2%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Retinal haemorrhage	1/46 (2.2%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Borderline glaucoma	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Cataract nuclear	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Conjunctival oedema	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Eye pruritus	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Eyelid ptosis	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Neovascular age-related macular degeneration	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Gastrointestinal disorders
Constipation	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Dental caries	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Immune system disorders
Seasonal allergy	3/46 (6.5%)		1/22 (4.5%)		0/10 (0%)		0/11 (0%)
Infections and infestations
Viral upper respiratory tract infection	4/46 (8.7%)		3/22 (13.6%)		1/10 (10%)		0/11 (0%)
Cystitis	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Sinusitis	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Tooth infection	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Injury, poisoning and procedural complications
Fall	3/46 (6.5%)		0/22 (0%)		0/10 (0%)		0/11 (0%)
Tooth fracture	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Investigations
Blood glucose increased	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Neutrophil count increased	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Prothrombin time prolonged	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
White blood cell count increased	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Musculoskeletal and connective tissue disorders
Bursitis	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Osteoarthritis	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma	1/46 (2.2%)		2/22 (9.1%)		0/10 (0%)		0/11 (0%)
Product Issues
Device breakage	0/46 (0%)		0/22 (0%)		1/10 (10%)		0/11 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)
Upper respiratory tract congestion	0/46 (0%)		0/22 (0%)		0/10 (0%)		1/11 (9.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.