Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00768040
• Collaborator: (none)
• Enrollment: 39
• Locations: 12
• Arms: 2
• Duration (Months): 29
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Aliskiren; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-masked, Placebo-controlled, add-on Study to Assess the Efficacy of Oral Aliskiren 300 mg Once Daily for Diabetic Macular Edema
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aliskiren 300 mg Aliskiren 300 mg once daily for 12 weeks	Drug: Aliskiren; 300 mg once daily; Other Names: SPP100
Placebo Comparator: Placebo Matching placebo once daily for 12 weeks	Drug: Placebo; Matching placebo once daily

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment [Baseline to week 12]

   The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Type 1 or type 2 diabetes

• Diabetic macular edema

Exclusion criteria:

• Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months)

• Recent laser photocoagulation in the study eye

• Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye

Other protocol-defined inclusion/exclusion criteria applied

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retinal Consultants of Arizona	Phoenix	Arizona	United States
2	Retina-Vitreous Associates	Los Angeles	California	United States
3	National Ophthalmic Research Institute	Fort Myers	Florida	United States
4	Georgia Retina	Atlanta	Georgia	United States
5	Elman Retina Group	Baltimore	Maryland	United States
6	Joslin Clinic	Boston	Massachusetts	United States	MA
7	Vitreo-Retinal Associates	Grand Rapids	Michigan	United States
8	Charlotte Eye, Ear, Nose and Throat Associate	Charlotte	North Carolina	United States	NC
9	Retina-Associates of Cleveland, Inc	Beachwood	Ohio	United States
10	Retinal Consultants of Houston	Houston	Texas	United States	TX
11	Novartis Investigative Site	Arhus		Denmark
12	Novartis Investigative Site	Copenhagen		Denmark

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00768040
• Other Study ID Numbers: CSPP100A2244; EudraCT 2008-00581-23
• First Posted: Oct 7, 2008
• Last Update Posted: Mar 6, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Novartis Pharmaceuticals: Diabetes; Macular edema; Aliskiren; Diabetic retinopathy; Diabetes mellitus type 1; Diabetes mellitus type 2
• Additional relevant MeSH terms: Macular Edema; Edema

Study Results

Participant Flow

Arm/Group Title	Aliskiren 300 mg	Placebo
Arm/Group Description	Aliskiren 300 mg once daily for 12 weeks	Matching placebo once daily for 12 weeks
Period Title: Overall Study
STARTED	20	19
COMPLETED	16	16
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Aliskiren 300 mg	Placebo	Total
Arm/Group Description	Aliskiren 300 mg once daily for 12 weeks	Matching placebo once daily for 12 weeks	Total of all reporting groups
Overall Participants	20	19	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.3 (10.76)	60.1 (10.57)	62.2 (10.74)
Age, Customized (participants) [Number]
18 - 64 years	9 45%	13 68.4%	22 56.4%
65 - 84 years	11 55%	6 31.6%	17 43.6%
Sex: Female, Male (Count of Participants)
Female	7 35%	4 21.1%	11 28.2%
Male	13 65%	15 78.9%	28 71.8%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment
Description	The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

This study was terminated early due to low recruitment of patients.

Arm/Group Title	Aliskiren 300 mg	Placebo
Arm/Group Description	Aliskiren 300 mg once daily for 12 weeks	Matching placebo once daily for 12 weeks
Measure Participants	0	0

Adverse Events

Arm/Group Title	Aliskiren 300mg		Placebo
Arm/Group Description	Aliskiren 300 mg once daily for 12 weeks		Matching placebo once daily for 12 weeks
All Cause Mortality
	Aliskiren 300mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Aliskiren 300mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/20 (10%)		2/19 (10.5%)
Infections and infestations
Cellulitis	1/20 (5%)		0/19 (0%)
Pneumonia	1/20 (5%)		0/19 (0%)
Pneumonia legionella	0/20 (0%)		1/19 (5.3%)
Metabolism and nutrition disorders
Diabetic foot	1/20 (5%)		0/19 (0%)
Nervous system disorders
Cerebrovascular accident	0/20 (0%)		1/19 (5.3%)
Other (Not Including Serious) Adverse Events
	Aliskiren 300mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/20 (65%)		9/19 (47.4%)
Cardiac disorders
Atrial fibrillation	0/20 (0%)		1/19 (5.3%)
Palpitations	0/20 (0%)		1/19 (5.3%)
Eye disorders
Cataract subcapsular	0/20 (0%)		1/19 (5.3%)
Choroidal neovascularisation	1/20 (5%)		0/19 (0%)
Foreign body sensation in eyes	1/20 (5%)		0/19 (0%)
Hyalosis asteroid	1/20 (5%)		0/19 (0%)
Macular oedema	1/20 (5%)		1/19 (5.3%)
Retinal exudates	0/20 (0%)		1/19 (5.3%)
Retinal neovascularisation	1/20 (5%)		0/19 (0%)
Vision blurred	1/20 (5%)		0/19 (0%)
Vitreous detachment	1/20 (5%)		0/19 (0%)
Gastrointestinal disorders
Abdominal pain upper	0/20 (0%)		1/19 (5.3%)
Diarrhoea	1/20 (5%)		0/19 (0%)
Flatulence	1/20 (5%)		0/19 (0%)
Oesophagitis	0/20 (0%)		1/19 (5.3%)
Vomiting	0/20 (0%)		2/19 (10.5%)
General disorders
Fatigue	1/20 (5%)		0/19 (0%)
Pyrexia	0/20 (0%)		1/19 (5.3%)
Immune system disorders
Seasonal allergy	1/20 (5%)		1/19 (5.3%)
Infections and infestations
Folliculitis	0/20 (0%)		1/19 (5.3%)
Fungal skin infection	1/20 (5%)		0/19 (0%)
Gastroenteritis viral	1/20 (5%)		1/19 (5.3%)
Respiratory tract infection	1/20 (5%)		0/19 (0%)
Sinusitis	1/20 (5%)		0/19 (0%)
Urinary tract infection	1/20 (5%)		1/19 (5.3%)
Injury, poisoning and procedural complications
Tooth fracture	1/20 (5%)		0/19 (0%)
Investigations
Blood pressure increased	0/20 (0%)		1/19 (5.3%)
Weight decreased	0/20 (0%)		1/19 (5.3%)
Metabolism and nutrition disorders
Decreased appetite	0/20 (0%)		1/19 (5.3%)
Diabetes mellitus	0/20 (0%)		1/19 (5.3%)
Hypoglycaemia	1/20 (5%)		0/19 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	1/20 (5%)		0/19 (0%)
Muscle spasms	1/20 (5%)		0/19 (0%)
Myalgia	1/20 (5%)		0/19 (0%)
Pain in extremity	1/20 (5%)		0/19 (0%)
Pain in jaw	1/20 (5%)		0/19 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	2/20 (10%)		0/19 (0%)
Nervous system disorders
Diabetic neuropathy	0/20 (0%)		1/19 (5.3%)
Dizziness	2/20 (10%)		2/19 (10.5%)
Headache	2/20 (10%)		2/19 (10.5%)
Paraesthesia	1/20 (5%)		0/19 (0%)
Sinus headache	0/20 (0%)		1/19 (5.3%)
Respiratory, thoracic and mediastinal disorders
Cough	0/20 (0%)		1/19 (5.3%)
Epistaxis	1/20 (5%)		0/19 (0%)
Oropharyngeal pain	0/20 (0%)		1/19 (5.3%)
Sinus congestion	0/20 (0%)		1/19 (5.3%)
Skin and subcutaneous tissue disorders
Dry skin	0/20 (0%)		1/19 (5.3%)
Vascular disorders
Hypertension	0/20 (0%)		1/19 (5.3%)
Hypotension	2/20 (10%)		0/19 (0%)

Limitations/Caveats

This study was terminated early due to low recruitment of patients. The study lacked power against the original objective of statistically significance for changes in central retinal thickness due to the much reduced sample size.

More Information

Certain Agreements

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

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.