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 differentBasic Trial Information
Disease | Status | Age | Sponsor | Protocol # | |
II | Diabetic Macular Edema | Recruting | 18-85 | Novartis | CSPP100A2244 |
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 MacularSite | Study Coordinator |
Beachwood | 216/831-5704 ext. 253 |


