Study to Assess the Efficacy and Safety of Monthly Octreotide Intramuscular Injections in Patients With Proliferative Diabetic Retinopathy After Lasercoagulation This Study is Not Being Conducted in the United States.

This study has been terminated.
(trial stopped on Sept 24, 2007)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170742
First received: September 9, 2005
Last updated: August 8, 2008
Last verified: August 2008
  Purpose

Phase III study comparing monthly octreotide i.m. in comparison to no additional treatment in patients with proliferative diabetic retinopathy after lasercoagulation.


Condition Intervention Phase
Proliferative Diabetic Retinopathy
Drug: Octreotide, 30 mg i.m. LAR formulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Controlled Study on the Efficacy and Safety of Octreotide i.m. in Patients With Proliferative Diabetic Retinopathy (PDR) After Start of Laser Coagulation

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • regression of neovascularization.

Secondary Outcome Measures:
  • Determine tolerability and safety

Estimated Enrollment: 17
Study Start Date: December 2003
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with type-I or type-II-diabetes mellitus.
  2. Males or females aged 18 - 70 years.
  3. Proliferative diabetic retinopathy (PDR) in at least one eye that has an ETDRS visual acuity score > 35 letters (20/200 or better), and that has no other condition that might interfere with assessment of retinopathy progression (see exclusion criterion #1).
  4. Media clarity, pupillary dilation and patient cooperation sufficient to allow stereoscopic 30°, or equivalent, fundus photographs of adequate quality in at least one eye that meets criterion #3 above.
  5. Starting of photocoagulation of at least one eye to treat PDR in between approximately 2 weeks prior to start of study.
  6. HbA1c < 13.0% at study entry. In addition, patients must be capable of testing their blood glucose levels at home and adjusting their insulin dosage to maintain blood glucose control.
  7. Systolic blood pressure < 180 mm Hg and diastolic blood pressure < 105 mm Hg at study entry.
  8. Females of childbearing potential must:

    • Have a negative pregnancy test prior to study entry.
    • Be practicing acceptable birth control measures inclusive of intrauterine devices or mechanical methods (i.e., oral contraceptives, vaginal diaphragm, vaginal sponge or condom with spermicide).
  9. Ability to read, understand and write German language
  10. Patients must give written informed consent to participate in this study.

Exclusion Criteria:

  1. Pretreatment as panretinal laser treatment other than photocoagulation which started approximately 2 weeks prior to start of study (see inclusion criteria # 5).
  2. Patients in whom the only otherwise eligible eye has, in the opinion of the investigator or of the central fundus photograph reading center, a condition that might interfere with assessment of retinopathy progression, including optic atrophy, extensive healed chorioretinitis, retinopathy that appears to have regressed spontaneously (with or without traction retinal detachment), retinal vascular occlusion, retinal degeneration, or other abnormality.
  3. Patients with a history of symptomatic gallstones who have not had a cholecystectomy (patients with asymptomatic cholelithiasis may be entered).
  4. Patients with brittle diabetes, type-I diabetes who have frequent decompensations in their glycemic control, with recurrent ketoacidosis or hypoglycemia that significantly interferes with their lifestyle.
  5. Patients with a history of severe hypoglycemia unawareness.
  6. Patients with a significant medical condition, other than diabetes mellitus, which may interfere with the evaluation of safety or efficacy of the study compound (e.g., unstable angina pectoris, myocardial infarction within 3 months prior to study entry, severe renal failure, patients on renal dialysis, patients who have received a renal transplant).
  7. Patients who have received any investigational drug within 4 weeks prior to study entry.
  8. Patients who have received prior treatment with Sandostatin or any other somatostatin analogue.
  9. History of non-compliance to medical regimens or who are considered potentially unreliable Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170742

Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Customer Information Novartis AG
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00170742     History of Changes
Other Study ID Numbers: CSMS 995 H DE 07
Study First Received: September 9, 2005
Last Updated: August 8, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Open label,
phase III,
disease,
clinical trial,
octreotide,
proliferative diabetic retinopathy, lasercoagulation

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 21, 2014