Proliferative Diabetic RetinopathyPhase 3NCT00170742
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.
A Phase 3 study testing Octreotide, 30 mg i.m. LAR formulation in people with Proliferative Diabetic Retinopathy, run by Novartis at 1 site in Switzerland.
Trial summary
Phase III study comparing monthly octreotide i.m. in comparison to no additional treatment in patients with proliferative diabetic retinopathy after lasercoagulation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Octreotide, 30 mg i.m. LAR formulation
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2003to May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type-I or type-II-diabetes mellitus.
- Males or females aged 18 - 70 years.
- 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).
- 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.
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- 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.
Who cannot join
- Pretreatment as panretinal laser treatment other than photocoagulation which started approximately 2 weeks prior to start of study (see inclusion criteria # 5).
- 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).
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- 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.
- History of non-compliance to medical regimens or who are considered potentially unreliable Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Octreotide, 30 mg i.m. LAR formulation
- Keywords
- Open label,, phase III,, disease,, clinical trial,, octreotide,, proliferative diabetic retinopathy, lasercoagulation
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide, 30 mg i.m. LAR formulationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
regression of neovascularization.
Secondary outcomes (1)
Determine tolerability and safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionMay 2006
Why it stopped: trial stopped on Sept 24, 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Customer Information, Study chair, Novartis AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170742
- Sponsor's protocol ID
- CSMS 995 H DE 07
- Status last verified
- Aug 2008
- First submitted
- 9 Sep 2005
- Last updated
- 12 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00170742
- Acronym / sponsor ID
- CSMS 995 H DE 07
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Open label,, phase III,, disease,, clinical trial,, octreotide,, proliferative diabetic retinopathy, lasercoagulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: trial stopped on Sept 24, 2007
- Enrolment
- 17 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- May 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase III study comparing monthly octreotide i.m. in comparison to no additional treatment in patients with proliferative diabetic retinopathy after lasercoagulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with type-I or type-II-diabetes mellitus.
- Males or females aged 18 - 70 years.
- 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).
- 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.
Key exclusion criteria (9 listed)
- Pretreatment as panretinal laser treatment other than photocoagulation which started approximately 2 weeks prior to start of study (see inclusion criteria # 5).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide, 30 mg i.m. LAR formulation | Drug | – |
Primary outcome
regression of neovascularization.
1 secondary outcome
Determine tolerability and safety
Results and safety
The study was stopped early (reason given: trial stopped on Sept 24, 2007). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Customer Information study chair
Novartis AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octreotide, 30 mg i.m. LAR formulation in people with Proliferative Diabetic Retinopathy, run by Novartis at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: trial stopped on Sept 24, 2007). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regression of neovascularization.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2008.