ZIMURA in Combination With LUCENTIS in Patients With Neovascular Age Related Macular Degeneration (NVAMD)

• Sponsor: Ophthotech Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03362190
• Collaborator: (none)
• Enrollment: 64
• Locations: 28
• Arms: 4
• Actual Duration (Months): 12.2
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)

Condition or Disease	Intervention/Treatment	Phase
Wet Age-related Macular Degeneration	Drug: Zimura; Drug: Lucentis	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
• Actual Study Start Date: Oct 11, 2017
• Actual Primary Completion Date: Oct 18, 2018
• Actual Study Completion Date: Oct 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Zimura dosage 1 + Lucentis 0.5 mg	Drug: Zimura; Zimura in combination with Lucentis; Other Names: avacincaptad pegol ; Drug: Lucentis; Zimura in combination with Lucentis; Other Names: ranibizumab
Experimental: Cohort 2 Zimura dosage 2 + Lucentis 0.5 mg	Drug: Zimura; Zimura in combination with Lucentis; Other Names: avacincaptad pegol ; Drug: Lucentis; Zimura in combination with Lucentis; Other Names: ranibizumab
Experimental: Cohort 3 Zimura dosage 3 + Lucentis 0.5 mg	Drug: Zimura; Zimura in combination with Lucentis; Other Names: avacincaptad pegol ; Drug: Lucentis; Zimura in combination with Lucentis; Other Names: ranibizumab
Experimental: Cohort 4 Zimura dosage 4 + Lucentis 0.5 mg	Drug: Zimura; Zimura in combination with Lucentis; Other Names: avacincaptad pegol ; Drug: Lucentis; Zimura in combination with Lucentis; Other Names: ranibizumab

Outcome Measures

Primary Outcome Measures

1. Systemic Adverse Events [6 months]

   Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)

2. Ophthalmic Adverse Events [6 months]

   Number of participants with ophthalmic Adverse Events (with calculated percentage)

Other Outcome Measures

1. Change From Baseline - ECG [6 months]

   Number of patients with a change on their Month 6 ECG when compared to their baseline ECG

2. Mean Change From Baseline - Study Eye ETDRS Visual Acuity [6 months]

   Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.

3. Mean Change From Baseline - Vital Signs [6 months]

   Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Active subfoveal NVAMD

Exclusion Criteria:

• History or evidence of severe cardiac disease

• Any major surgical procedure within one month of trial entry

• Subjects with a clinically significant laboratory value

• Any treatment with an investigational agent in the past 60 days for any condition

• Women who are pregnant or nursing

• Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation

• Any prior treatment for AMD other than oral supplements of vitamins and minerals

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Research Institute	Phoenix	Arizona	United States	85053
2	Retina Centers PC	Tucson	Arizona	United States	85704
3	Retina Associates SW, PC	Tucson	Arizona	United States	85710
4	Retina-Vitreous Associates Medical Group	Beverly Hills	California	United States	90211
5	Retina Consultants of Orange County	Fullerton	California	United States	92835
6	Retina Consultants of Southern California	Redlands	California	United States	92374
7	Retinal Consultants Medical Group	Sacramento	California	United States	95841
8	Orange County Retina Medical Group	Santa Ana	California	United States	92705
9	Colorado Retina Associates	Golden	Colorado	United States	80214
10	Florida Eye Clinic	Altamonte Springs	Florida	United States	32701
11	Florida Eye Associates	Melbourne	Florida	United States	32901
12	Illinois Eye Center	Peoria	Illinois	United States	61615
13	Vitreo Retinal Consultants & Surgeons	Wichita	Kansas	United States	67214
14	Ophthalmic Consultants of Boston	Boston	Massachusetts	United States	02114
15	VitreoRetinal Surgery	Minneapolis	Minnesota	United States	55435
16	Retina Consultants of Nevada	Henderson	Nevada	United States	89052
17	Sierra Eye Associates	Reno	Nevada	United States	89502
18	Retina Vitreous Surgeons of CNY, PC	Syracuse	New York	United States	13224
19	Retina Northwest PC	Portland	Oregon	United States	97221
20	Mid Atlantic Retina	Philadelphia	Pennsylvania	United States	19107
21	Charleston Neuroscience Institute	Ladson	South Carolina	United States	29456
22	Retina Research Institute of Texas	Abilene	Texas	United States	79606
23	Strategic Clinical Research Group	Willow Park	Texas	United States	76087
24	Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont	Budapest		Hungary	1076
25	Budapest Retina Associates	Budapest		Hungary	1133
26	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szemeszeti Klinika	Szeged		Hungary	6702
27	Pauls Stradins Clinical University Hospital, Clinic of Ophthalmology	Riga		Latvia	LV-1002
28	Dr. Solomatin's eye rehabilitation and vision correction centre	Riga		Latvia	LV-1050

Sponsors and Collaborators

• Ophthotech Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Aug 9, 2017
• Statistical Analysis Plan - Sep 25, 2018

More Information

Publications

None provided.

• Responsible Party: Ophthotech Corporation
• ClinicalTrials.gov Identifier: NCT03362190
• Other Study ID Numbers: OPH2007
• First Posted: Dec 5, 2017
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ophthotech Corporation: Zimura; ARC1905; Lucentis; ranibizumab; Wet AMD; avacincaptad pegol; complement factor C5 inhibitor
• Additional relevant MeSH terms: Macular Degeneration; Ranibizumab

Study Results

Participant Flow

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Arm/Group Description	Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg	Monthly administration of Zimura 2mg + Lucentis 0.5 mg administered (given on the same day)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5mg (Total: 6 doses of Zimura & 3 doses Lucentis)
Period Title: Overall Study
STARTED	10	10	22	22
COMPLETED	10	10	22	20
NOT COMPLETED	0	0	0	2

Baseline Characteristics

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Total
Arm/Group Description	Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg	Monthly administration of Zimura 2mg + Lucentis 0.5 mg (given on the same day)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)	Total of all reporting groups
Overall Participants	10	10	22	22	64
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	2 20%	0 0%	2 9.1%	1 4.5%	5 7.8%
>=65 years	8 80%	10 100%	20 90.9%	21 95.5%	59 92.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.7 (11.27)	77.9 (6.62)	74.1 (7.41)	78.1 (7.40)	76.0 (8.07)
Sex: Female, Male (Count of Participants)
Female	4 40%	8 80%	14 63.6%	12 54.5%	38 59.4%
Male	6 60%	2 20%	8 36.4%	10 45.5%	26 40.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	1 4.5%	1 4.5%	2 3.1%
Not Hispanic or Latino	10 100%	10 100%	21 95.5%	21 95.5%	62 96.9%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	10 100%	10 100%	22 100%	22 100%	64 100%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Latvia	0 0%	1 10%	2 9.1%	3 13.6%	6 9.4%
Hungary	0 0%	3 30%	8 36.4%	2 9.1%	13 20.3%
United States	10 100%	6 60%	12 54.5%	17 77.3%	45 70.3%
ETDRS Visual Acuity -Study Eye (number of letters read) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of letters read]	53.9 (9.0)	51.5 (5.4)	52.5 (9.4)	53.2 (9.9)	52.8 (8.9)

Outcome Measures

1. Primary Outcome

Title	Systemic Adverse Events
Description	Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Arm/Group Description	Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg	Monthly administration of Zimura 2mg + Lucentis 0.5mg (given on the same day)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly adminstration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses Zimura & 3 doses of Lucentis)
Measure Participants	10	10	22	22
All causalities	6 60%	5 50%	5 22.7%	11 50%
Related to study drugs	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Ophthalmic Adverse Events
Description	Number of participants with ophthalmic Adverse Events (with calculated percentage)
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Arm/Group Description	Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg	Monthly administration of Zimura 2mg + Lucentis 0.5mg (given on the same day)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2mg + Lucentis 0.5 mg (Total: 6 doses of Zimura & 3 doses Lucentis)
Measure Participants	10	10	22	22
Participants with all causality events in the fellow eye	1 10%	1 10%	0 0%	2 9.1%
Participants with all causality events in the study eye	8 80%	4 40%	11 50%	15 68.2%
Participants with event related to injection procedure in the study eye	8 80%	4 40%	10 45.5%	12 54.5%
Participants with event related to injection procedure in the fellow eye	0 0%	0 0%	0 0%	0 0%
Participants with event related to study drugs in the study eye	0 0%	0 0%	0 0%	0 0%
Participants with event related to study drugs in the fellow eye	0 0%	0 0%	0 0%	0 0%

3. Other Pre-specified Outcome

Title	Change From Baseline - ECG
Description	Number of patients with a change on their Month 6 ECG when compared to their baseline ECG
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Arm/Group Description	Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg	Monthly administration of Zimura 2mg + Lucentis 0.5 mg (given on the same day)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)
Measure Participants	10	10	22	22
No Change	7 70%	5 50%	18 81.8%	12 54.5%
Not Clinically Signigicant Change	3 30%	5 50%	3 13.6%	6 27.3%
Clinically Significant Change	0 0%	0 0%	0 0%	1 4.5%
Missing	0 0%	0 0%	1 4.5%	3 13.6%

4. Other Pre-specified Outcome

Title	Mean Change From Baseline - Study Eye ETDRS Visual Acuity
Description	Mean change from Baseline to Month 6 in the number of letters read by the study eye using the ETDRS Visual Acuity charts. Higher ETDRS letters represents better vision and a larger change in ETDRS letters represents better functioning.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

safety population

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Arm/Group Description	Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg	Monthly administration of Zimura 2mg + Lucentis 0.5 mg (given on the same day)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)
Measure Participants	10	10	22	22
Mean (Standard Deviation) [number of letters read]	9.0 (11.0)	10.2 (18.7)	10.7 (10.3)	9.9 (8.2)

5. Other Pre-specified Outcome

Title	Mean Change From Baseline - Vital Signs
Description	Mean change from Baseline to Month 6 in blood pressure (mm Hg). A negative number indicates a decrease and a positive number indicates an increase.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

safety population

Arm/Group Title	Cohort 1	Cohort 2	Cohort 3	Cohort 4
Arm/Group Description	Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4mg	Monthly administration of Zimura 2mg + Lucentis 0.5 mg (given on the same day)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)	Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Lucentis 0.5mg + Zimura 2mg (6 doses of Zimura and 3 doses of Lucentis)
Measure Participants	10	10	22	22
Systolic blood pressure (mm Hg)	-12.0 (15.04)	0.7 (8.92)	-1.9 (14.92)	-5.8 (18.24)
Diastolic blood pressure (mm Hg)	-3.2 (7.93)	-7.9 (12.32)	-4.7 (11.83)	-0.4 (8.24)

Adverse Events

Time Frame	6 months
Arm/Group Title	Cohort 1		Cohort 2		Cohort 3		Cohort 4
Arm/Group Description	Monthly administration of Lucentis 0.5 mg followed 2 days later by Zimura 4 mg		Monthly administration of Zimura 2 mg + Lucentis 0.5 mg (given on the same day)		Zimura 2mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses of Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg + Lucentis 0.5mg given on the same day (Total: 3 doses of Zimura and 3 doses of Lucentis)		Zimura 2 mg + Lucentis 0.5 mg Induction Phase (Day 1 - Month 2): Monthly administration of Zimura 2 mg + Lucentis 0.5 mg given on the same day followed 14 days later with Zimura 2mg (Total: 6 doses of Zimura & 3 doses Lucentis) Maintenance Phase (Month 3-5): Monthly administration of Zimura 2mg followed 2 days later by Zimura 2 mg + Lucentis 0.5 mg (Total: 6 doses of Zimura & 3 doses Lucentis)
All Cause Mortality
	Cohort 1		Cohort 2		Cohort 3		Cohort 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/22 (0%)		0/22 (0%)
Serious Adverse Events
	Cohort 1		Cohort 2		Cohort 3		Cohort 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		1/10 (10%)		0/22 (0%)		2/22 (9.1%)
Eye disorders
Retinal detachment	0/10 (0%)	0	0/10 (0%)	0	0/22 (0%)	0	1/22 (4.5%)	1
Metabolism and nutrition disorders
Diabetic ketoacidosis	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/10 (0%)	0	0/10 (0%)	0	0/22 (0%)	0	1/22 (4.5%)	1
Other (Not Including Serious) Adverse Events
	Cohort 1		Cohort 2		Cohort 3		Cohort 4
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/10 (100%)		7/10 (70%)		10/22 (45.5%)		13/22 (59.1%)
Eye disorders
Conjunctival haemorrhage	6/10 (60%)	14	1/10 (10%)	1	5/22 (22.7%)	6	6/22 (27.3%)	12
Vitreous floaters	0/10 (0%)	0	0/10 (0%)	0	3/22 (13.6%)	3	3/22 (13.6%)	3
Punctate keratitis	2/10 (20%)	2	1/10 (10%)	1	1/22 (4.5%)	1	1/22 (4.5%)	2
Conjunctival hyperaemia	1/10 (10%)	1	1/10 (10%)	1	1/22 (4.5%)	1	2/22 (9.1%)	5
Eye pain	1/10 (10%)	3	0/10 (0%)	0	0/22 (0%)	0	3/22 (13.6%)	6
Corneal oedema	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	2/22 (9.1%)	3
Ocular discomfort	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	2/22 (9.1%)	2
Retinal haemorrhage	0/10 (0%)	0	0/10 (0%)	0	1/22 (4.5%)	1	2/22 (9.1%)	2
Vitreous detachment	0/10 (0%)	0	1/10 (10%)	1	2/22 (9.1%)	2	0/22 (0%)	0
Lacrimation increased	1/10 (10%)	1	0/10 (0%)	0	1/22 (4.5%)	1	0/22 (0%)	0
Visual acuity reduced	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	1/22 (4.5%)	1
Visual impairment	0/10 (0%)	0	0/10 (0%)	0	0/22 (0%)	0	2/22 (9.1%)	2
Retinal artery occlusion	0/10 (0%)	0	1/10 (10%)	3	0/22 (0%)	0	0/22 (0%)	0
Subretinal fibrosis	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	0/22 (0%)	0
Vitreous opacities	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
cataract	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	1/22 (4.5%)	1
Neovascular age-related macular degeneration	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	0/22 (0%)	0
Gastrointestinal disorders
Diarrhoea	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
Hiatus hernia	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	0/22 (0%)	0
Infections and infestations
Nasopharyngitis	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	1/22 (4.5%)	1
Upper respiratory tract infection	1/10 (10%)	2	0/10 (0%)	0	0/22 (0%)	0	1/22 (4.5%)	1
Herpes zoster	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
Tooth infection	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
Urinary tract infection	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	0/22 (0%)	0
Injury, poisoning and procedural complications
Fall	2/10 (20%)	2	0/10 (0%)	0	1/22 (4.5%)	1	1/22 (4.5%)	1
Contusion	2/10 (20%)	2	0/10 (0%)	0	0/22 (0%)	0	0/22 (0%)	0
Laceration	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	0/22 (0%)	0
Corneal abrasion	1/10 (10%)	1	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
Investigations
Intraocular pressure increased	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	1/22 (4.5%)	2
Metabolism and nutrition disorders
Vitamin B complex deficiency	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	0/22 (0%)	0
Vitamin D deficiency	1/10 (10%)	1	0/10 (0%)	0	0/22 (0%)	0	0/22 (0%)	0
Nervous system disorders
Syncope	1/10 (10%)	1	0/10 (0%)	0	1/22 (4.5%)	1	0/22 (0%)	0
Psychiatric disorders
Anxiety	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	1/22 (4.5%)	1
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
Urticaria	0/10 (0%)	0	1/10 (10%)	1	0/22 (0%)	0	0/22 (0%)	0
Vascular disorders
Hypertension	1/10 (10%)	1	0/10 (0%)	0	1/22 (4.5%)	1	0/22 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Institution/PI agrees not to individually publish the results of the Study without IVERIC bio's prior written consent. Institution/PI may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of IVERIC bio.