Trial Outcomes & Findings for Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration (NCT NCT01157065)

Last Updated: 2013-06-04

Results Overview

The thickness of the retina was measured using a non-invasive device that produces cross-sectional and 3D images of the eye. The reduction was calculated by subtracting Week 4 visit value from the Baseline value. A positive number indicates a reduction in thickness compared to baseline, whereas a negative number indicates an increase in thickness. An increase in thickness as compared to baseline may indicate a progression of the underlying disease.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

99 participants

Primary outcome timeframe

Week 4

Results posted on

2013-06-04

Participant Flow

Subjects were recruited from 14 study centers in the US.

Of the 99 subjects enrolled, 48 were considered screen failures and were exited from the study prior to randomization. Of the 51 subjects randomized, 2 did not receive treatment. This reporting group includes all randomized subjects who received study medication.

Participant milestones

Participant milestones
Measure	AL-78898A Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up	Lucentis Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Overall Study STARTED	38	11
Overall Study COMPLETED	38	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AL-78898A Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up	Lucentis Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Overall Study Death	0	1

Baseline Characteristics

Evaluation of AL-78898A in Exudative Age-Related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AL-78898A n=38 Participants Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up	Lucentis n=11 Participants Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up	Total n=49 Participants Total of all reporting groups
Age, Customized 18 to 64 years	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Age, Customized ≥65 years	35 participants n=5 Participants	11 participants n=7 Participants	46 participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	4 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	11 participants n=7 Participants	49 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: All patients who received study medication, completed at least one scheduled post-injection study visit, and did not receive standard therapy prior to Week 4 assessment

Outcome measures

Outcome measures
Measure	AL-78898A n=24 Participants Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up	Lucentis n=10 Participants Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4 Baseline	514.2 microns Standard Deviation 158	551.8 microns Standard Deviation 119.0
Mean Reduction From Baseline in Central Subfield (CSF) Retinal Thickness at Week 4 Week 4	-12.1 microns Standard Deviation 87.2	199.9 microns Standard Deviation 139.6

PRIMARY outcome

Timeframe: Up to Day 30

Population: Intent-to-treat (ITT): All patients who received study medication and completed at least one scheduled post-injection study visit

An ESI was a protocol-specified event of scientific and medical concern specific to the Sponsor's product or program where ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. These adverse events could have been serious or nonserious and may have required further investigation in order to characterize and understand.

Outcome measures

Outcome measures
Measure	AL-78898A n=38 Participants Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up	Lucentis n=11 Participants Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Incidence of Events of Special Interest (ESI)	2 events	0 events

Adverse Events

AL-78898A

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Lucentis

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AL-78898A n=38 participants at risk Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up	Lucentis n=11 participants at risk Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Nervous system disorders Cerebrovascular Accident	2.6% 1/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	0.00% 0/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Injury, poisoning and procedural complications Fall	2.6% 1/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	0.00% 0/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Nervous system disorders Syncope	2.6% 1/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	0.00% 0/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Nervous system disorders Transient ischaemic attack	5.3% 2/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	0.00% 0/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
General disorders Death	0.00% 0/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	9.1% 1/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.

Other adverse events

Other adverse events
Measure	AL-78898A n=38 participants at risk Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up	Lucentis n=11 participants at risk Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
Eye disorders Conjunctival haemorrhage	18.4% 7/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	9.1% 1/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Eye disorders Eye irritation	7.9% 3/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	0.00% 0/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Eye disorders Vitreous floaters	7.9% 3/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	0.00% 0/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Eye disorders Retinal pigment epithelial tear	5.3% 2/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	0.00% 0/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Eye disorders Eye pruritis	0.00% 0/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	9.1% 1/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Eye disorders Lens disorder	0.00% 0/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	9.1% 1/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Eye disorders Macular degeneration	0.00% 0/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	9.1% 1/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Eye disorders Open angle glaucoma	0.00% 0/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	9.1% 1/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Infections and infestations Nasopharyngitis	5.3% 2/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	9.1% 1/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Infections and infestations Urinary tract infection	2.6% 1/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	9.1% 1/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.
Psychiatric disorders Insomnia	7.9% 3/38 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.	0.00% 0/11 • Adverse events were collected for the duration of the study. This reporting group includes all randomized subjects who received study medication. An adverse event was defined as any untoward medical occurrence in a patient who was administered a study treatment regardless of whether or not the event had a causal relationship with the treatment. Adverse events were obtained as solicited comments from the study patients and as observations by the Investigator as outlined in the study protocol.

Additional Information

Mehdi Hosseini, Clinical Trial Manager

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

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