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Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00695318
Recruitment Status : Terminated
First Posted : June 11, 2008
Results First Posted : May 29, 2015
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age-Related Macular Degeneration
Intervention Drug: Fluocinolone Acetonide
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A, 2, I 0.2 µg/Day + Sham A, 2, II 0.5 µg/Day + Sham
Hide Arm/Group Description

0.2 µg/Day

Fluocinolone Acetonide: 0.2 µg/Day

0.5 µg/Day

Fluocinolone Acetonide: 0.5 µg/Day

Period Title: Overall Study
Started 10 7
Completed 5 6
Not Completed 5 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             2             0
Death             1             1
Study Terminated             1             0
Arm/Group Title A, 2, I 0.2 µg/Day + Sham A, 2, II 0.5 µg/Day + Sham Total
Hide Arm/Group Description

0.2 µg/Day

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

0.5 µg/Day

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

Total of all reporting groups
Overall Number of Baseline Participants 10 7 17
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 7 participants 17 participants
79.95  (8.976) 82.55  (6.056) 81.02  (7.799)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 17 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 17 participants
Female
2
  20.0%
1
  14.3%
3
  17.6%
Male
8
  80.0%
6
  85.7%
14
  82.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 7 participants 17 participants
10 7 17
1.Primary Outcome
Title Change From Baseline in Size of Geographic Atrophy
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients received either a 0.2µg/Day or 0.5 µg/Day treatment in the study eye and a sham treatment in the fellow eye.
Arm/Group Title A, 2, I Sham A, 2, I 0.2 µg/Day A, 2, II Sham A, 2, II 0.5 µg/Day
Hide Arm/Group Description:
[Not Specified]

0.2 µg/Day

Fluocinolone Acetonide: 0.2 µg/Day

[Not Specified]

0.5 µg/Day

Fluocinolone Acetonide: 0.5 µg/Day

Overall Number of Participants Analyzed 8 8 6 6
Mean (Standard Deviation)
Unit of Measure: mm3/year
2.513  (1.5318) 2.758  (1.7830) 2.599  (2.4005) 2.562  (1.9685)
Time Frame [Not Specified]
Adverse Event Reporting Description Each patient received a sham injection in one eye and active treatment in the other eye.
 
Arm/Group Title Sham Injection 0.2 ug/Day 0.5 ug/Day 0.2 ug/Day + Sham Injection 0.5 ug/Day + Sham Injection
Hide Arm/Group Description

Sham Injection

Sham Injection: Sham injection

Ocular AEs

0.2 µg/Day

Fluocinolone Acetonide: 0.2 µg/Day

Ocular AEs

0.5 µg/Day

Fluocinolone Acetonide: 0.5 µg/Day

Ocular AEs

Fluocinolone Acetonide: 0.2 µg/Day + Sham Injection

Systemic AEs

Fluocinolone Acetonide: 0.5 µg/Day + Sham Injection

Systemic AEs

All-Cause Mortality
Sham Injection 0.2 ug/Day 0.5 ug/Day 0.2 ug/Day + Sham Injection 0.5 ug/Day + Sham Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Sham Injection 0.2 ug/Day 0.5 ug/Day 0.2 ug/Day + Sham Injection 0.5 ug/Day + Sham Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/17 (17.65%)      3/10 (30.00%)      2/7 (28.57%)      3/10 (30.00%)      5/7 (71.43%)    
Blood and lymphatic system disorders           
Anaemia  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Cardiac disorders           
Myocardial infarction  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Ventricular tachycardia  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Gastrointestinal disorders           
Oesophageal achalasia  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations           
Sepsis  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Metabolism and nutrition disorders           
Dehydration  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Lactic acidosis  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Nervous system disorders           
Cerebral haemorrhage  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Cerebrovascular accident  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  2
Renal and urinary disorders           
Renal mass  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Pneumonia aspiration  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Pulmonary oedema  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Surgical and medical procedures           
Cataract operation  1  3/17 (17.65%)  3 3/10 (30.00%)  3 2/7 (28.57%)  2 0/0  0 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham Injection 0.2 ug/Day 0.5 ug/Day 0.2 ug/Day + Sham Injection 0.5 ug/Day + Sham Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/17 (58.82%)      8/10 (80.00%)      7/7 (100.00%)      5/10 (50.00%)      6/7 (85.71%)    
Cardiac disorders           
Cardiac failure congestive  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Eye disorders           
Blepharitis  1  1/17 (5.88%)  1 1/10 (10.00%)  1 0/7 (0.00%)  0 0/0  0 0/0  0
Cataract  1  3/17 (17.65%)  3 3/10 (30.00%)  4 2/7 (28.57%)  3 0/0  0 0/0  0
Cataract subcapsular  1  1/17 (5.88%)  1 0/10 (0.00%)  0 1/7 (14.29%)  1 0/0  0 0/0  0
Choroidal neovascularisation  1  0/17 (0.00%)  0 1/10 (10.00%)  1 0/7 (0.00%)  0 0/0  0 0/0  0
Conjunctival haemorrhage  1  2/17 (11.76%)  2 2/10 (20.00%)  2 1/7 (14.29%)  1 0/0  0 0/0  0
Conjunctival hyperaemia  1  1/17 (5.88%)  1 2/10 (20.00%)  2 1/7 (14.29%)  1 0/0  0 0/0  0
Dacryostenosis acquired  1  1/17 (5.88%)  1 0/10 (0.00%)  0 0/7 (0.00%)  0 0/0  0 0/0  0
Dry eye  1  2/17 (11.76%)  2 1/10 (10.00%)  1 1/7 (14.29%)  1 0/0  0 0/0  0
Eye irritation  1  0/17 (0.00%)  0 1/10 (10.00%)  1 0/7 (0.00%)  0 0/0  0 0/0  0
Eye pain  1  0/17 (0.00%)  0 2/10 (20.00%)  2 0/7 (0.00%)  0 0/0  0 0/0  0
Eyelid ptosis  1  1/17 (5.88%)  1 1/10 (10.00%)  1 0/7 (0.00%)  0 0/0  0 0/0  0
Myodesopsia  1  0/17 (0.00%)  0 2/10 (20.00%)  2 1/7 (14.29%)  2 0/0  0 0/0  0
Photophobia  1  1/17 (5.88%)  1 1/10 (10.00%)  1 0/7 (0.00%)  0 0/0  0 0/0  0
Posterior capsule opacification  1  1/17 (5.88%)  1 0/10 (0.00%)  0 0/7 (0.00%)  0 0/0  0 0/0  0
Punctate keratitis  1  5/17 (29.41%)  7 3/10 (30.00%)  3 3/7 (42.86%)  5 0/0  0 0/0  0
Retinal pigment epithelial tear  1  0/17 (0.00%)  0 1/10 (10.00%)  1 0/7 (0.00%)  0 0/0  0 0/0  0
Vision blurred  1  1/17 (5.88%)  1 0/10 (0.00%)  0 0/7 (0.00%)  0 0/0  0 0/0  0
Visual impairment  1  1/17 (5.88%)  1 2/10 (20.00%)  2 1/7 (14.29%)  1 0/0  0 0/0  0
Vitreous detachment  1  0/17 (0.00%)  0 0/10 (0.00%)  0 1/7 (14.29%)  1 0/0  0 0/0  0
Infections and infestations           
Pneumonia  1  0/0  0 0/0  0 0/0  0 2/10 (20.00%)  2 0/7 (0.00%)  0
Upper respiratory tract infection  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Urinary tract infection  1  0/0  0 0/0  0 0/0  0 2/10 (20.00%)  2 1/7 (14.29%)  1
Injury, poisoning and procedural complications           
Upper limb fracture  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Investigations           
Heart rate irregular  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Intraocular pressure increased  1  1/17 (5.88%)  1 1/10 (10.00%)  1 3/7 (42.86%)  3 0/0  0 0/0  0
Metabolism and nutrition disorders           
Dehydration  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  2
Type 2 diabetes mellitus  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Breast cancer  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Skin cancer  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Renal and urinary disorders           
Nephrolithiasis  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure  1  0/0  0 0/0  0 0/0  0 0/10 (0.00%)  0 1/7 (14.29%)  1
Chronic obstructive pulmonary disease  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Hypoxia  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders           
Cutis laxa  1  1/17 (5.88%)  1 1/10 (10.00%)  1 0/7 (0.00%)  0 0/0  0 0/0  0
Vascular disorders           
Phlebitis  1  0/0  0 0/0  0 0/0  0 1/10 (10.00%)  1 0/7 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathleen Billman, Senior Director, Scientific Affairs
Organization: Alimera Sciences, Inc.
Phone: 678-527-1302
EMail: kathleen.billman@alimerasciences.com
Layout table for additonal information
Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00695318    
Other Study ID Numbers: C-01-08-004
First Submitted: June 9, 2008
First Posted: June 11, 2008
Results First Submitted: April 17, 2015
Results First Posted: May 29, 2015
Last Update Posted: May 29, 2015