Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.).
To provide use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients with rubeosis iridis. Rubeosis iridis refers to neovascularization of the iris. It is caused by a number of conditions which include, but are not limited to severe diabetic retinopathy, central retinal vein occlusion, chronic inflammation, and infection. Anecortave acetate is an angiostatic, experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD). Therefore, it is logical to apply the usage of Anecortave to patient’s with rubeosis iridis in order to reduce the neovascularization stimulus and cause the regression of the abnormal iris vessels.
Severe Diabetic Retinopathy
Central Retinal Vein Occlusion
Drug: anecortave acetate
Manhattan Eye, Ear & Throat Hospital has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension (15mg.).|
- tyo investigate the use of anecortave acetate in rubeosis iridis [ Time Frame: 24 months ]
- mean change in VA(ETDRS) from baseline to 24 months [ Time Frame: 24 months ]
|Study Start Date:||March 2002|
|Study Completion Date:||May 2007|
Patients will receive an injection of 15 mg of Anecortave acetate behind the eye to be treated (“study eye”). They will be evaluated every six months to determine if their condition is stable or worse. Following the injection of study medication, patients will not be required to come in to see the study physician. The investigator or study staff will call the patients on the day following injection to make sure there were no adverse effects to the injection. Patients will then come in for a Week 4 and Month 3 follow-up visit. At the Month 3 follow-up visit, if patients are not showing stability or improvement, they may be offered either thermal laser or Photodynamic Therapy. They will remain in the study and remain eligible for a repeat injection of Anecortave Acetate at the Month 6 visit.
Patients will then been seen at Month 6 for a Re-treatment Evaluation Visit. If their condition is stable, they will be offered re-injection with the same study medication they received earlier. If Patients are not showing stability or improvement at the Month 6 visit, they may be offered thermal laser or Photodynamic Therapy in conjunction with the Anecortave Acetate injection.
If the patient is re-injected at the 6 month visit, the schedule of follow-up visits will repeat as before for the next 18 months. If the patient opts out of the re-injection, they will be exited from the study.
|United States, New York|
|Manhattan Eye, Ear & Throat Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||Lawrence A. Yannuzzi, MD||Manhattan Eye, Ear & Throat Hospital|