Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT00695318
First received: June 9, 2008
Last updated: May 11, 2015
Last verified: May 2015
Results First Received: April 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Age-Related Macular Degeneration
Intervention: Drug: Fluocinolone Acetonide

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A, 2, I 0.2 µg/Day + Sham

0.2 µg/Day

Fluocinolone Acetonide: 0.2 µg/Day

A, 2, II 0.5 µg/Day + Sham

0.5 µg/Day

Fluocinolone Acetonide: 0.5 µg/Day


Participant Flow:   Overall Study
    A, 2, I 0.2 µg/Day + Sham     A, 2, II 0.5 µg/Day + Sham  
STARTED     10     7  
COMPLETED     5     6  
NOT COMPLETED     5     1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 2                 0  
Death                 1                 1  
Study Terminated                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients received either the 0.2µ/day or 0.5µ /day dose as well as a sham injection in the fellow eye. The total number of subjects enrolled/analyzed was 17.

Reporting Groups
  Description
A, 2, I 0.2 µg/Day + Sham

0.2 µg/Day

Fluocinolone Acetonide: 0.2 µg/Day + Sham treatment in fellow eye

A, 2, II 0.5 µg/Day + Sham

0.5 µg/Day

Fluocinolone Acetonide: 0.5 µg/Day + Sham treatment in fellow eye

Total Total of all reporting groups

Baseline Measures
    A, 2, I 0.2 µg/Day + Sham     A, 2, II 0.5 µg/Day + Sham     Total  
Number of Participants  
[units: participants]
  10     7     17  
Age  
[units: years]
Mean (Standard Deviation)
  79.95  (8.976)     82.55  (6.056)     81.02  (7.799)  
Age, Customized  
[units: participants]
     
<35 years     0     0     0  
35-44 years     0     0     0  
45-54 years     0     0     0  
55-64 years     1     0     1  
65-74 years     1     1     2  
75-84 years     5     2     7  
≥85 years     3     4     7  
Gender  
[units: participants]
     
Female     2     1     3  
Male     8     6     14  
Region of Enrollment  
[units: participants]
     
United States     10     7     17  



  Outcome Measures

1.  Primary:   Change From Baseline in Size of Geographic Atrophy   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kathleen Billman, Senior Director, Scientific Affairs
Organization: Alimera Sciences, Inc.
phone: 678-527-1302
e-mail: kathleen.billman@alimerasciences.com


No publications provided


Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00695318     History of Changes
Other Study ID Numbers: C-01-08-004
Study First Received: June 9, 2008
Results First Received: April 17, 2015
Last Updated: May 11, 2015
Health Authority: United States: Food and Drug Administration