Macular EdemaPhase 3NCT00806169
Combined Triple Therapy in Diabetic Retinopathy (DRP)
A Phase 3 study testing triamcinolone and bevacizumab in people with Macular Edema and Diabetic Retinopathy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Macular Edema, Diabetic Retinopathy
- What is being tested?
- triamcinolone and bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2006to Nov 2008
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetic retinopathy
- macular edema more than 200 micron
- vitreous bleeding because of angiography documented NVEs NVDs, based on the definitions of ETDRS
Who cannot join
- Prior intraocular injection within 4 months
- Core or complete vitrectomy
- History of glaucoma or ocular hypertension
- Presence of iris neovascularization
- Significant media opacity
- Monocularity and pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Vitreoretinal Surgery
Frankfurt am Main, Hesse, 60590
About this study
Official title: Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy
The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.
Read the detailed description
This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.
- Conditions
- Macular Edema, Diabetic Retinopathy
- Being tested
- triamcinolone and bevacizumab
- Keywords
- combined therapy, DRP, efficacy, safety, sustainability, macular edema due to DRP
- Medical subject headings
- Macular Edema, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone and bevacizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | group I (n=17) nonproliferative DR and ischemic maculopathy Receives: Drug: triamcinolone and bevacizumab |
| 2 | Experimental | group II (n=38) nonproliferative DR without ischemic maculopathy Receives: Drug: triamcinolone and bevacizumab |
| 3 | Experimental | group III (n=18) proliferative DR with or without ischemic maculopathy Receives: Drug: triamcinolone and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Measured: Day of exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startApr 2006
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Koss, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806169
- Sponsor's protocol ID
- MK-KTDRP-2008
- Status last verified
- Sep 2012
- First submitted
- 4 Dec 2008
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Combination Therapy Using Triamcinolone and Bevacizumab Improves Vision in Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00806169
- Acronym / sponsor ID
- MK-KTDRP-2008
- Conditions
- Macular Edema, Diabetic Retinopathy
- Keywords
- combined therapy, DRP, efficacy, safety, sustainability, macular edema due to DRP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Dec 2008 (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 aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with macular edema due to diabetic retinopathy.
Detailed description
This prospective, monocenter pilot case series was conducted between May 2006 and November 2008. Patients were included because of DME and signs of pre- and early proliferation because of diabetic retinopathy.73 eyes of 56 patients were included, all of which had signed an informed consent to perform a pharmacosurgical procedure consisting of a 23 gauge core Pars Plana Vitrectomy (sutureless single stitch sclerotomy, cutter with 300 cuts/minute) with removement of 1.5ml vitreous and substitution with 1ml BSS, 8mg triamcinolone, and 1.25 mg bevacizumab. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: triamcinolone and bevacizumabgroup I (n=17) nonproliferative DR and ischemic maculopathy |
| 2 | Experimental | Drug: triamcinolone and bevacizumabgroup II (n=38) nonproliferative DR without ischemic maculopathy |
| 3 | Experimental | Drug: triamcinolone and bevacizumabgroup III (n=18) proliferative DR with or without ischemic maculopathy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetic retinopathy
Key exclusion criteria (6 listed)
- Prior intraocular injection within 4 months
- Core or complete vitrectomy
- History of glaucoma or ocular hypertension
- Presence of iris neovascularization
- Significant media opacity
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 |
|---|---|---|
| triamcinolone and bevacizumab | Drug | 1, 2, 3 |
Primary outcome
Best Corrected Visual Acuity
Time frame: Day of exam
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 27 Sep 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 triamcinolone and bevacizumab in people with Macular Edema and Diabetic Retinopathy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 3 inclusion and 6 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 27 Sep 2012. 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 Germany. 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 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?
Best Corrected Visual Acuity (time frame: Day of exam). 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 27 Sep 2012.