Trial Outcomes & Findings for A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD) (NCT NCT01603043)

NCT ID: NCT01603043

Last Updated: 2014-01-20

Results Overview

Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Day 0 (injection visit), Month 12
• Results posted on: 2014-01-20

Participant Flow

Participants were recruited from 7 study centers located in the United States.

Participant milestones

Measure	AL-78898A 1 intravitreal injection per month for up to 12 months	Sham Injection 1 mock injection per month for 12 months
Overall Study STARTED	7	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Measure	AL-78898A 1 intravitreal injection per month for up to 12 months	Sham Injection 1 mock injection per month for 12 months
Overall Study Study Futility	7	3

Baseline Characteristics

A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)

Baseline characteristics by cohort

Measure	AL-78898A n=7 Participants 1 intravitreal injection per month for up to 12 months	Sham Injection n=3 Participants 1 mock injection per month for 12 months	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (injection visit), Month 12

Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 0), up to Month 12

Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 0), Month 12

Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.

Outcome measures

Outcome data not reported

Adverse Events

AL-78898A

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Sham Injection

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AL-78898A n=7 participants at risk 1 intravitreal injection per month for up to 12 months	Sham Injection n=3 participants at risk 1 mock injection per month for 12 months
Eye disorders Conjunctival haemorrhage	28.6% 2/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	33.3% 1/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Eye disorders Eye pruritus	14.3% 1/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	0.00% 0/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Eye disorders Ocular hyperaemia	14.3% 1/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	0.00% 0/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Eye disorders Retinal oedema	0.00% 0/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	33.3% 1/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Eye disorders Vitreous floaters	14.3% 1/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	0.00% 0/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Eye disorders Vitreous haemorrhage	14.3% 1/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	0.00% 0/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
General disorders Product deposit	57.1% 4/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	0.00% 0/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Infections and infestations Herpes zoster	0.00% 0/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	33.3% 1/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Injury, poisoning and procedural complications Excoriation	14.3% 1/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	0.00% 0/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Injury, poisoning and procedural complications Injury	14.3% 1/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	0.00% 0/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Surgical and medical procedures Dental implantation	14.3% 1/7 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"	0.00% 0/3 • Adverse events were collected for the duration of the study (6 months). An Adverse Event (AE) was defined as any untoward medical occurrence in a patient administered a study treatment regardless of causal relationship. At each visit, after the patient had the opportunity to spontaneously mention any problems, the Investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"

Additional Information

Yamini Patel, PhD, Clinical Lead

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER