Diabetic RetinopathyPhase 3NCT00131144
Octreotide Acetate in Microspheres in Patients With Diabetic Retinopathy
A Phase 3 study testing Octreotide Acetate in Microspheres 20 mg and Octreotide Acetate in Microspheres in people with Diabetic Retinopathy, run by Novartis at 1 site in United States.
Trial summary
The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Octreotide Acetate in Microspheres 20 mg and Octreotide Acetate in Microspheres
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 583 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1999to Dec 2005
- 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
- Males and females with type 1 and type 2 diabetes mellitus
- Moderately severe or severe NPDR or mild PDR in at least one eye:
- with an Early Treatment Diabetic Retinopathy Study (ETDRS) visual score of > 35 letters; and
- not previously treated with scatter photocoagulation.
- HbA1c < 13% at study entry
Who cannot join
- Condition which could interfere with the assessment of retinopathy progression
- History of symptomatic gallstones without cholecystectomy
- Brittle diabetes or history of severe hypoglycemia unawareness
- Previous treatment with a somatostatin analogue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study on the Efficacy and Safety of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferate Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.
- Conditions
- Diabetic Retinopathy
- Being tested
- Octreotide Acetate in Microspheres 20 mg, Octreotide Acetate in Microspheres, Placebo
- Keywords
- Diabetic retinopathy,Octreotide Acetate in Microspheres
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide Acetate in Microspheres 20 mgDrug
Octreotide Acetate in MicrospheresDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Octreotide Acetate in Microspheres 20 mg | Experimental | 20 mg will be administered im once every 4 weeks Receives: Drug: Octreotide Acetate in Microspheres 20 mg |
| Octreotide Acetate in Microspheres 30 mg | Experimental | 30 mg will be administered im once every 4 weeks Receives: Drug: Octreotide Acetate in Microspheres |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to progression of diabetic retinopathy
Measured: throughout study
Secondary outcomes (2)
time to development or progression of macular edema, and
Measured: Baseline through end of study
time to moderate vision loss
Measured: Baseline through end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startNov 1999
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Customer Information, Study chair, East Hanover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131144
- Sponsor's protocol ID
- CSMS995 0802
- Status last verified
- Nov 2011
- First submitted
- 16 Aug 2005
- Last updated
- 17 Nov 2011
- Results posted
- No
Publications
Pivonello R, Muscogiuri G, Holder G, Paul M, Sarp S, Lesogor A, Jordaan P, Eisinger J, Colao A. Long-term safety of long-acting octreotide in patients with diabetic retinopathy: results of pooled data from 2 randomized, double-blind, placebo-controlled phase 3 studies. Endocrine. 2018 Apr;60(1):65-72. doi: 10.1007/s12020-017-1448-5. Epub 2017 Nov 7.
PubMed 29116540
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study on the Efficacy and Safety of Octreotide Acetate in Microspheres in the Therapy of Patients With Moderately Severe or Severe Non-proliferate Diabetic Retinopathy (NPDR) or Low Risk Proliferative Diabetic Retinopathy (PDR)
- ClinicalTrials.gov ID
- NCT00131144
- Acronym / sponsor ID
- CSMS995 0802
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic retinopathy,Octreotide Acetate in Microspheres
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 17 Aug 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.
The most common ocular disease in patients with diabetes, diabetic retinopathy, is present in approximately 40% of diabetic patients; about 8% of diabetic patients have vision threatening diabetic retinopathy. Although intensive control of blood glucose has been shown to reduce the development and progression of diabetic retinopathy, intensive control of glucose is usually not achieved in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Octreotide Acetate in Microspheres 20 mg | Experimental | Drug: Octreotide Acetate in Microspheres 20 mg20 mg will be administered im once every 4 weeks |
| Octreotide Acetate in Microspheres 30 mg | Experimental | Drug: Octreotide Acetate in Microspheres30 mg will be administered im once every 4 weeks |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females with type 1 and type 2 diabetes mellitus
- Moderately severe or severe NPDR or mild PDR in at least one eye:
- HbA1c < 13% at study entry
Key exclusion criteria (4 listed)
- Condition which could interfere with the assessment of retinopathy progression
- History of symptomatic gallstones without cholecystectomy
- Brittle diabetes or history of severe hypoglycemia unawareness
- Previous treatment with a somatostatin analogue
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 Acetate in Microspheres 20 mg | Drug | Octreotide Acetate in Microspheres 20 mg |
| Octreotide Acetate in Microspheres | Drug | Octreotide Acetate in Microspheres 30 mg |
| Placebo | Drug | Placebo |
Primary outcome
time to progression of diabetic retinopathy
Time frame: throughout study
2 secondary outcomes
time to development or progression of macular edema, and
Time frame: Baseline through end of study
time to moderate vision loss
Time frame: Baseline through end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
- Derived from this study: PubMed 29116540Pivonello R, Muscogiuri G, Holder G, Paul M, Sarp S, Lesogor A, Jordaan P, Eisinger J, Colao A. Long-term safety of long-acting octreotide in patients with diabetic retinopathy: results of pooled data from 2 randomized, double-blind, placebo-controlled phase 3 studies. Endocrine. 2018 Apr;60(1):65-72. doi: 10.1007/s12020-017-1448-5. Epub 2017 Nov 7.
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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
East Hanover
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 Acetate in Microspheres 20 mg and Octreotide Acetate in Microspheres in people with Diabetic Retinopathy, run by Novartis at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 17 Nov 2011. 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 United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to progression of diabetic retinopathy (time frame: throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131144, which also lists 1 linked publication.
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 17 Nov 2011.