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.

NCT00170742 | Terminated Phase 3

• 1 other identifier: CSMS 995 H DE 07
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Proliferative Diabetic Retinopathy

Keywords

Open label,; phase III,; disease,; clinical trial,; octreotide,; proliferative diabetic retinopathy, lasercoagulation

Outcome Measures

Primary Outcomes (1)

• regression of neovascularization.

Secondary Outcomes (1)

• Determine tolerability and safety

Interventions

Octreotide, 30 mg i.m. LAR formulation DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type-I or type-II-diabetes mellitus.
• Males or females aged 18 - 70 years.
• 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.
• Starting of photocoagulation of at least one eye to treat PDR in between approximately 2 weeks prior to start of study.
• 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.
• Systolic blood pressure \< 180 mm Hg and diastolic blood pressure \< 105 mm Hg at study entry.
• 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).
• Ability to read, understand and write German language
• Patients must give written informed consent to participate in this study.

You may not qualify if:

• 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.
• Patients with a history of symptomatic gallstones who have not had a cholecystectomy (patients with asymptomatic cholelithiasis may be entered).
• 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.
• Patients with a history of severe hypoglycemia unawareness.
• 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).
• Patients who have received any investigational drug within 4 weeks prior to study entry.
• Patients who have received prior treatment with Sandostatin or any other somatostatin analogue.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Basel, Switzerland

Location

MeSH Terms

Conditions

Disease

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Novartis Customer Information

  Novartis AG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 2003
• Primary Completion: May 1, 2006
• Last Updated: August 12, 2008

Record last verified: 2008-08

Locations

CH (1)