Avacincaptad Pegol Open-Label Extension for Patients With... | NCT05536297

ID	Type	Description	Link
2022-002860-59	EudraCT Number
2024-515185-13-00	Registry Identifier	CTIS (EU)

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
avacincaptad pegol	Experimental	Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.	Drug: avacincaptad pegol

Name	Type	Description	Arm Group Labels	Other Names
avacincaptad pegol	Drug	Intravitreal Injection	avacincaptad pegol	Zimura (previous name)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs)	An AE is defined as any untoward medical occurrence in a participant including unfavorable and unintended signs, symptoms or disease temporally associated with the use of a medicinal product and which does not necessarily have to have a causal relationship to this treatment. AEs include illnesses with onset during the trial, or exacerbations of pre-existing illnesses. Exacerbation of pre-existing illness is defined as a significant increase in the severity of the illness as compared to the start of the trial and was considered when a participant requires new or additional treatment for that illness. Lack of or insufficient clinical response or efficacy was not recorded as an AE.	Up to 18 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Anti-drug Antibody (ADA)	Number of participants with ADA = Post-baseline positive (in Baseline negative group) + treatment-boosted ADA positive (in Baseline positive group) / participants with a Baseline and at least one post-baseline sample. For participants whose ADA status is positive at Baseline, a post-baseline titer value that is >= 4 times higher than the Baseline is considered treatment-boosted ADA.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director	Astellas Pharma Global Development, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Retinal Diagnostic Center		Campbell	California	95008	United States
Eye Medical Center of Fresno

References Module

Label	URL
Link to plain language summary of the study on the Trial Results Summaries website.	View source
Link to results and other applicable study documents on the Astellas Clinical Trials website.	View source

ID	Title	Description
FG000	ACP Every Month (EM) to ACP EM	All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 27, 2024	Mar 26, 2026

Categories

Title	Measurements
	BG00075.9± 9.3 BG00178.6± 8.1 BG00277.9± 8.4 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
In Utero	BG0000 BG0010 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00046 BG00138 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0005 BG0014 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG00057 BG00147 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a participant including unfavorable and unintended signs, symptoms or disease temporally associated with the use of a medicinal product and which does not necessarily have to have a causal relationship to this treatment.

AEs include illnesses with onset during the trial, or exacerbations of pre-existing illnesses. Exacerbation of pre-existing illness is defined as a significant increase in the severity of the illness as compared to the start of the trial and was considered when a participant requires new or additional treatment for that illness. Lack of or insufficient clinical response or efficacy was not recorded as an AE.

Safety Analysis Set included all participants who were administered at least 1 dose of study drug.

Posted

Count of Participants

Participants

Up to 18 months

ID	Title	Description
OG000	ACP EM to ACP EM	All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
OG001	ACP EM/EOM to ACP EM	All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
OG002	Sham to ACP EM	All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.

Units	Counts
Participants	OG00064 OG00161 OG002151

Title

Denominators

Categories

Title	Measurements
	OG00050 OG00149 OG002129

Secondary

Number of Participants With Anti-drug Antibody (ADA)

Number of participants with ADA = Post-baseline positive (in Baseline negative group) + treatment-boosted ADA positive (in Baseline positive group) / participants with a Baseline and at least one post-baseline sample.

For participants whose ADA status is positive at Baseline, a post-baseline titer value that is >= 4 times higher than the Baseline is considered treatment-boosted ADA.

Anti-drug Antibody Analysis Set included all treated participants with at least 1 valid anti-drug antibody result.

Posted

Count of Participants

Participants

Up to 18 months

ID	Title	Description
OG000	ACP EM to ACP EM	All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
OG001	ACP EM/EOM to ACP EM	All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
OG002

Secondary

Plasma Concentrations of ACP

Concentrations below the lower limit of quantification (3.36 ng/mL) are set to zero for calculation of summary statistics.

Pharmacokinetic Analysis Set included all treated participants with at least 1 valid plasma concentrations result.

Posted

Mean

Standard Deviation

ng/mL

Months 1, 2, 4, 7, 13, and 18

ID	Title	Description
OG000	ACP EM to ACP EM	All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
OG001	ACP EM/EOM to ACP EM	All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
OG002	Sham to ACP EM	All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ACP EM to ACP EM	All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.	0	64	14	64	42	64
EG001	ACPEM/EOM to ACP EM	All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.	2	62	13	61	39	61
EG002	Sham to ACP EM	All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.	3	152	24	151	93	151

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Angina unstable	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Cardiac failure	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Cardiac failure acute	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Myocardial infarction	Cardiac disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Cataract	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Choroidal neovascularisation	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0023 events2 affected151 at risk
Dry age-related macular degeneration	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Endophthalmitis	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Visual acuity reduced	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0022 events2 affected151 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Colitis	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Melaena	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Bronchitis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Cellulitis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Device related infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Pneumonia	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected61 at risk EG0021 events1 affected151 at risk
Septic shock	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0022 events2 affected151 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Spinal cord injury cauda equina	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Intraocular pressure increased	Investigations	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Pancreatogenous diabetes	Metabolism and nutrition disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0022 events2 affected151 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Cerebral haematoma	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk EG0020 events0 affected151 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Completed suicide	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Mental disorder	Psychiatric disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk EG0020 events0 affected151 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Pleural fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0022 events2 affected151 at risk
Aortic valve replacement	Surgical and medical procedures	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk
Vascular graft	Surgical and medical procedures	MedDRA v24.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0010 events0 affected61 at risk EG0021 events1 affected151 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cataract	Eye disorders	MedDRA v24.0	Systematic Assessment	EG00010 events6 affected64 at risk EG00117 events10 affected61 at risk EG00217 events14 affected151 at risk
Choroidal neovascularisation	Eye disorders	MedDRA v24.0	Systematic Assessment	EG00011 events10 affected64 at risk EG0013 events3 affected61 at risk EG00223 events20 affected151 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA v24.0	Systematic Assessment	EG00026 events7 affected64 at risk EG00134 events6 affected61 at risk EG00264 events17 affected151 at risk
Posterior capsule opacification	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0013 events3 affected61 at risk EG0028 events8 affected151 at risk
Punctate keratitis	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0003 events2 affected64 at risk EG0012 events2 affected61 at risk EG0029 events9 affected151 at risk
Visual acuity reduced	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0005 events4 affected64 at risk EG0013 events3 affected61 at risk EG00223 events18 affected151 at risk
Vitreous detachment	Eye disorders	MedDRA v24.0	Systematic Assessment	EG0004 events4 affected64 at risk EG0014 events4 affected61 at risk EG0023 events3 affected151 at risk
Bronchitis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected64 at risk EG0014 events4 affected61 at risk EG0023 events3 affected151 at risk
COVID-19	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0008 events8 affected64 at risk EG0015 events5 affected61 at risk EG0029 events9 affected151 at risk
Influenza	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0002 events2 affected64 at risk EG0012 events2 affected61 at risk EG0028 events8 affected151 at risk
Nasopharyngitis	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0004 events4 affected64 at risk EG0011 events1 affected61 at risk EG00210 events9 affected151 at risk
Urinary tract infection	Infections and infestations	MedDRA v24.0	Systematic Assessment	EG0006 events5 affected64 at risk EG0012 events2 affected61 at risk EG00213 events11 affected151 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v24.0	Systematic Assessment	EG0009 events9 affected64 at risk EG0017 events4 affected61 at risk EG00214 events12 affected151 at risk
Intraocular pressure increased	Investigations	MedDRA v24.0	Systematic Assessment	EG00013 events9 affected64 at risk EG00118 events10 affected61 at risk EG00254 events21 affected151 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v24.0	Systematic Assessment	EG0004 events4 affected64 at risk EG0011 events1 affected61 at risk EG0022 events2 affected151 at risk

ID	Term
D057092	Geographic Atrophy
D008268	Macular Degeneration

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

ID	Title	Description
BG000	ACP EM to ACP EM	All participants who received ACP EM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
BG001	ACP EM/EOM to ACP EM	All participants who received ACP EM through the Month 11 visit and then were randomized to ACP at Month 12 and administered ACP EOM through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
BG002	Sham to ACP EM	All participants who received sham through the Month 23 visit in study ISEE2008 (NCT04435366) and then enrolled in this study (ISEE2009) and received ACP 2 mg EM open-label from Month 1 through Month 17 followed by a non-interventional Month 18 study visit.
BG003	Total	Total of all reporting groups