Diabetic Retinal EdemaPhase 4NCT03590444
Treatment of Diabetic Macular Edema (DME) With Anti-VEGF and Focal Laser
A Phase 4 study testing Ranibizumab 0.5 MG/0.05 ML Intraocular Solution in people with Diabetic Retinal Edema, run by Hospital Hietzing at 1 site in Austria.
Trial summary
Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinal Edema
- What is being tested?
- Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 2 Apr 2017to 2 Jun 2018
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- DME that will be detected clinically and on FA as well as on SD-OCT [diffuse macular edema with central retinal thickness (CRT) ≥300µm involving the center of the macular area]
- Patients will be included into the present study following informed consent
- Best-corrected-visual-acuity (BCVA) between 0.06 (1.2logMAR) and 0.63 (0.20logMAR).
Who cannot join
- Eyes with other retinal diseases [i.e. age-related macular degeneration (AMD) and associated choroidal neovascularization (CNV), cystoid macular edema (CME) of other origin (e.g. uveitis, Irvine-Gass syndrome, retinal vein occlusion), or retinal dystrophies]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Diabetic Macular Edema (DME) With Intravitreal Anti-vascular Endothelial Growth Factor (Anti-VEGF) and Prompt Versus Deferred Focal Laser During Long-term Follow-up and Identification of Prognostic Retinal Markers
Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.
Read the detailed description
Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.
Prospective clinical trial (50 treatment-naive eyes) with DME randomized 1:1 receiving intravitreal ranibizumab (0.5 mg/0.05 ml) and prompt grid laser compared to ranibizumab and deferred laser. Morphological characteristics potentially relevant for prognosis were assessed at baseline, month 6, month 9, year 1, 2, 3, 4 and 5 of follow-up.
Grid laser and ranibizumab therapy is expected to be effective in DME management during long-term follow-up. Immediate combined therapy will likely signify a trend of functional superiority in an early disease phase. Intraretinal hyperreflective material in SD-OCT will likely negatively related to BCVA.
- Conditions
- Diabetic Retinal Edema
- Being tested
- Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5 MG/0.05 ML Intraocular SolutionDrug
Also called Focal grid laser
Focal laser treatment will be performed using argon laser photocoagulation (VISULAS 532s®, Carl Zeiss Meditec) operating at 532nm and Ranibizumab 0.5 MG/0.05 ML Intraocular Solution.
Ranibizumab 0.5 MG/0.05 ML Intraocular Solution
| Study group | Role | What they receive |
|---|---|---|
| Prompt laser group | Active comparator | Eyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on the same day (prompt' group, 25 eyes, 50%).
Interventions: ranibizumab and focal/grid laser on the same day [Ranibizumab (Ranibizumab 0.5 MG/0.05 ML Intraocular Solution] Receives: Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution |
| Deferred laser group | Active comparator | Eyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on one week prior to laser treatment (deferred' group, 25 eyes, 50%).
Interventions: ranibizumab and focal/grid laser on one week prior to laser treatment [Ranibizumab 0.5 MG/0.05 ML Intraocular Solution] Receives: Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents
Measured: 1 year
Secondary outcomes (2)
Additional morphological characteristics in spectral Domain SD-OCT
Intraretinal morphological features found in SD- OCT Imaging (i.e. intraretinal morphological changes senn on SD-OCT).
Measured: 1 year
Central retinal thickness
Morphological alterations will be followed during treatment phase, essential for verification of treatment success. Units: Micrometer (retinal thickness)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start2 Apr 2017
- Primary completion2 Apr 2018
- Study completion2 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Hietzing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Schütze, Ass.Prof., MD, PhD, Hospital Hietzing
- Investigators
- Christopher Schütze, Ass.Prof. MD, Principal investigator, Hietzing Hospital Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590444
- Sponsor's protocol ID
- EK 10-147-0910
- Status last verified
- Jul 2018
- First submitted
- 14 Jun 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Diabetic Macular Edema (DME) With Intravitreal Anti-vascular Endothelial Growth Factor (Anti-VEGF) and Prompt Versus Deferred Focal Laser During Long-term Follow-up and Identification of Prognostic Retinal Markers
- ClinicalTrials.gov ID
- NCT03590444
- Acronym / sponsor ID
- EK 10-147-0910
- Conditions
- Diabetic Retinal Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Study start
- 2 Apr 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Jun 2018 (actual)
- First posted
- 18 Jul 2018 (actual)
- 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.
Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.
Detailed description
Long-term follow-up of patients with diabetic macular edema (DME) treated with intravitreal anti-vascular endothelial growth factor (anti-VEGF) combined focal laser and identification of prognostic morphological characteristics.
Prospective clinical trial (50 treatment-naive eyes) with DME randomized 1:1 receiving intravitreal ranibizumab (0.5 mg/0.05 ml) and prompt grid laser compared to ranibizumab and deferred laser. Morphological characteristics potentially relevant for prognosis were assessed at baseline, month 6, month 9, year 1, 2, 3, 4 and 5 of follow-up.
Grid laser and ranibizumab therapy is expected to be effective in DME management during long-term follow-up. Immediate combined therapy will likely signify a trend of functional superiority in an early disease phase. Intraretinal hyperreflective material in SD-OCT will likely negatively related to BCVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prompt laser group | Active comparator | Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular SolutionEyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on the same day (prompt' group, 25 eyes, 50%). Interventions: ranibizumab and focal/grid laser on the same day [Ranibizumab (Ranibizumab 0.5 MG/0.05 ML Intraocular Solution] |
| Deferred laser group | Active comparator | Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular SolutionEyes of eligible patients will be randomized (ratio 1:1) and receive ranibizumab and focal/grid laser on one week prior to laser treatment (deferred' group, 25 eyes, 50%). Interventions: ranibizumab and focal/grid laser on one week prior to laser treatment [Ranibizumab 0.5 MG/0.05 ML Intraocular Solution] |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- DME that will be detected clinically and on FA as well as on SD-OCT [diffuse macular edema with central retinal thickness (CRT) ≥300µm involving the center of the macular area]
- Patients will be included into the present study following informed consent
- Best-corrected-visual-acuity (BCVA) between 0.06 (1.2logMAR) and 0.63 (0.20logMAR).
Key exclusion criteria (1 listed)
- Eyes with other retinal diseases [i.e. age-related macular degeneration (AMD) and associated choroidal neovascularization (CNV), cystoid macular edema (CME) of other origin (e.g. uveitis, Irvine-Gass syndrome, retinal vein occlusion), or retinal dystrophies]
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 |
|---|---|---|
| Ranibizumab 0.5 MG/0.05 ML Intraocular SolutionAlso: Focal grid laserFocal laser treatment will be performed using argon laser photocoagulation (VISULAS 532s®, Carl Zeiss Meditec) operating at 532nm and Ranibizumab 0.5 MG/0.05 ML Intraocular Solution. Ranibizumab 0.5 MG/0.05 ML Intraocular Solution | Drug | Deferred laser group, Prompt laser group |
Primary outcome
Visual acuity
Time frame: 1 year
Functional alterations will be followed during treatment phase, essential for verification of treatment success. Units: Snellen equivalents
2 secondary outcomes
Additional morphological characteristics in spectral Domain SD-OCT
Time frame: 1 year
Central retinal thickness
Time frame: 1 year
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 18 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Christopher Schütze, Ass.Prof. MD principal investigator
Hietzing Hospital Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab 0.5 MG/0.05 ML Intraocular Solution in people with Diabetic Retinal Edema, run by Hospital Hietzing at 1 site in Austria.
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 1 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 18 Jul 2018. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Visual acuity (time frame: 1 year). 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 18 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.