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Research & Clinical Trials

Study Detail: Novartis- AIM

Trial Description

Summary :  This study is evaluating whether an FDA approved medication for hypertension (Aliskeren/Tekturna) can be effective for a different indication.  The study will assess the effectiveness of this drug to reduce swelling of the retina associated with Diabetic Macular Edema.

Basic Trial Information

Phase

Disease

Status

Age

Sponsor

Protocol #

II

Diabetic Macular Edema

Recruting

18-85

Novartis

CSPP100A2244

Study Duration:  3 months (though screening for study can add up to 3 additional months)

Eligibility Criteria:

Inclusion Criteria

  • ME secondary to diabetes with central subfield > 280um.
  • It must be safe to withhold Laser, IVS, and IV VEGF inhibitors, in the study eye for duration of the study.
  • Can have received IVK, laser or IV VEGF inhibitors as long as it has been greater than 3 months from screening.

 Exclusion Criteria

OPHTHALMIC EXCLUSION- BCVA >20/320 at screening or baseline

·         Mac atrophy/scar/fibrosis/exudates in study eye that would preclude improvement in V.A.

·         Any progressive disease of retina or optic nerve other than diabetic retinopathy

·         Media opacity in study eye severe enough to interfere w/ a 3 line improvement in VA compared to baseline

·         PDR or pre proliferative that may need focal therapy w/in 16 weeks of screening.

·         IOP of >25mmHg in either eye at screening.

·         Any intra- ocular sx. in study eye except uncomplicated CE < 6months ā screening.

·         Laser in study eye w/in 3 mos ā study.

·         No IVK or anti VEGF inhibitors 3mo ā screening.

·         Use of any drug toxic to retina, lens, or optic nerve. (e.g., hyrochloroquine, ethambutaol, deferoxamine)

·         Any abnormal lab work as defined by the study.

GENERAL MEDICAL EXCLUSION-

  • HBA1C > 10.  BP > 155/95.  Weigh > 110 lbs. BMI 18-40kg/m2. GFR <50ml/min. K+ >5.0
  • Any Coronary history w/in 6mo ā screening.  Hx. Of heart block or pacemaker at any time.
  • See coordinator for complete list of medical exclusions.
  • Multiple cardiac exclusions. Have coordinator review history.
  • Hx. Of angioedema from ACE inhibitors, ARBs, or aliskiren therapy.
  • Use of chronic nasal/oral corticosteroids of any type, bronchodilators, MAO inhibitors, sympathomimetics, or

Ergotoids. Coordinator has more complete list.

BMI 18-40 kg/m. Must weigh at least 50kg. (110

Study Title :  A Phase II, randomized, double-masked , placebo controlled, add on study to assess the efficacy of oral aliskiren 300mg once daily for Diabetic Macular Edema.

Trial Contact Information

Site

Study Coordinator

Beachwood

216/831-5704 ext. 253