Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)

This study has been terminated.

(Sponsor decision)

Sponsor:

Information provided by:

CoMentis

ClinicalTrials.gov Identifier:

NCT00414206

First received: December 19, 2006

Last updated: October 26, 2010

Last verified: October 2010

History of Changes

Results First Received: August 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Macular Degeneration
Interventions:	Drug: Mecamylamine Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
1% Mecamylamine	No text entered.
0.3% Mecamylamine	No text entered.
Placebo	No text entered.

Participant Flow: Overall Study

	1% Mecamylamine	0.3% Mecamylamine	Placebo
STARTED	115	114	114
COMPLETED	57	58	59
NOT COMPLETED	58	56	55

Baseline Characteristics

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Reporting Groups

	Description
1% Mecamylamine	No text entered.
0.3% Mecamylamine	No text entered.
Placebo	No text entered.
Total	Total of all reporting groups

Baseline Measures

	1% Mecamylamine	0.3% Mecamylamine	Placebo	Total
Number of Participants [units: participants]	115	114	114	343
Age [units: years] Mean ± Standard Deviation	73.2 ± 8	72.6 ± 8.7	71.3 ± 7.7	72.4 ± 8.2
Gender [units: participants]
Female	65	71	77	213
Male	50	43	37	130
Region of Enrollment [units: participants]
Czech Republic	11	15	12	38
Mexico	7	7	6	20
Brazil	15	13	16	44
Poland	19	21	17	57
Ukraine	34	32	35	101
Russian Federation	26	26	28	80
United States	3	0	0	3

Outcome Measures

1. Primary:

Proportion of Subjects Losing Fewer Than 15 ETDRS Letters of Visual Acuity at 48 Weeks Compared to Baseline. [ Time Frame: Baseline to Week 48 ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
1% Mecamylamine	No text entered.
0.3% Mecamylamine	No text entered.
Placebo	No text entered.

Other Adverse Events

	1% Mecamylamine	0.3% Mecamylamine	Placebo
Total, other (not including serious) adverse events
# participants affected / at risk	68/115	57/114	57/114
Cardiac disorders
Cardiac disorders
# participants affected / at risk	4/115 (3.48%)	8/114 (7.02%)	4/114 (3.51%)
# events	4	8	4
Eye disorders
Visual acuity reduced
# participants affected / at risk	38/115 (33.04%)	31/114 (27.19%)	38/114 (33.33%)
# events	38	31	38
Retinal haemorrhage
# participants affected / at risk	17/115 (14.78%)	11/114 (9.65%)	16/114 (14.04%)
# events	17	11	16
Cataract
# participants affected / at risk	7/115 (6.09%)	0/114 (0.00%)	1/114 (0.88%)
# events	7	0	1
Gastrointestinal disorders
Gastrointestinal disorders
# participants affected / at risk	9/115 (7.83%)	5/114 (4.39%)	8/114 (7.02%)
# events	9	5	8
Infections and infestations
Infections and Infestiations
# participants affected / at risk	19/115 (16.52%)	16/114 (14.04%)	12/114 (10.53%)
# events	19	16	12
Investigations
Investigations
# participants affected / at risk	4/115 (3.48%)	6/114 (5.26%)	7/114 (6.14%)
# events	4	6	7
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
# participants affected / at risk	8/115 (6.96%)	5/114 (4.39%)	4/114 (3.51%)
# events	8	5	4
Nervous system disorders
Nervous system disorders
# participants affected / at risk	15/115 (13.04%)	2/114 (1.75%)	9/114 (7.89%)
# events	15	2	9
Headache
# participants affected / at risk	6/115 (5.22%)	2/114 (1.75%)	4/114 (3.51%)
# events	6	2	4
Vascular disorders
Vascular disorders
# participants affected / at risk	6/115 (5.22%)	3/114 (2.63%)	6/114 (5.26%)
# events	6	3	6

More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Carl Grove
Organization: CoMentis, Inc.
phone: 650-869-7600
e-mail: cgrove@comentis.com

No publications provided

Responsible Party:	Carl Grove, CoMentis, Inc.
ClinicalTrials.gov Identifier:	NCT00414206 History of Changes
Other Study ID Numbers:	ATG003-201
Study First Received:	December 19, 2006
Results First Received:	August 16, 2010
Last Updated:	October 26, 2010
Health Authority:	United States: Food and Drug Administration Ukraine: Ministry of Health

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