Diabetic Macular EdemaPhase 4ReCaLLNCT02059772
Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema
A Phase 4 study testing ranibizumab and micropulse diode laser in people with Diabetic Macular Edema, run by GWT-TUD GmbH at 1 site in Germany.
Trial summary
The primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- ranibizumab and micropulse diode laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 30 Apr 2014to 31 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of non-ischemic diabetic macular edema with resulting reduction in visual functionality by determination of best corrected visual acuity (BCVA), ophthalmologic investigation, SD-OCT, FAG and anamnesis
- BCVA between 0.05 and 0.6 or retinal thickness > 300 µm determined by SD-OCT
- The informed consent form must be signed before any study specific tests or procedures are done
- Confirmation of the subject's health insurance coverage prior to the first screening visit
- Age at least 18 years (inclusive) at the first screening visit
- Ability to understand and follow study-related instructions
Who cannot join
- Severe ischemic maculopathy of the study eye
- Active neovascularization of iris or retina in the study eye
- History of intravitreal injection of VEGF-inhibitor or steroids in study eye within the last 3 month
- Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract)
- Advanced glaucoma with central defects of the visual field in study eye
- Retinal pathologies with reduced visus (e.g. central scars, age related macular degeneration) in study eye
Show all 16Show fewer
- Retinal vascular occlusion in medical history of study eye
- Active or suspected ocular or periocular infections
- Active intraocular inflammation in study eye
- Intraocular surgery of study eye within the last 6 months
- Laser therapy of study eye within the last 6 months
- Systemic steroid therapy within the last 3 month
- HbA1c >10%
- Systolic blood pressure above 170 mmHg and diastolic blood pressure above 110 mmHg (after at least 3 min in supine position)
- Pregnant or breast-feeding woman and woman without adequate method of contraception.
- Known hypersensitivity to the active substance or to any of the excipients
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Augenheilkunde, Klinikum Chemnitz gGmbH
Chemnitz, 09116
About this study
Official title: Evaluation of an Additional Therapeutic Approach to Diabetic Macular Edema by Combining Standard Therapy (Intravitreal Injection of a VEGF-inhibitor) With Micropulse Diode Laser Treatment in a Randomized, Controlled Proof of Concept Study
The primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).
- Conditions
- Diabetic Macular Edema
- Being tested
- ranibizumab, micropulse diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
micropulse diode laserProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Standard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC Receives: Drug: ranibizumab |
| Treatment Group | Experimental | Combination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment Receives: Drug: ranibizumab; Procedure: micropulse diode laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in best corrected visual acuity (BCVA)
Measured: baseline, 12 month
Secondary outcomes (2)
change in central macular thickness
Measured: baseline, 12 month
number of intravitreal Lucentis injections
Measured: within 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study start30 Apr 2014
- Primary completionNov 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Klio Ai Becker, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059772
- Sponsor's protocol ID
- ReCaLL-2013
- Acronym
- ReCaLL
- Status last verified
- Feb 2017
- First submitted
- 10 Feb 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Furashova O, Strassburger P, Becker KA, Engelmann K. Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema (ReCaLL): a single center, randomised, controlled, non-inferiority clinical trial. BMC Ophthalmol. 2020 Jul 29;20(1):308. doi: 10.1186/s12886-020-01576-w.
PubMed 32727496
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Additional Therapeutic Approach to Diabetic Macular Edema by Combining Standard Therapy (Intravitreal Injection of a VEGF-inhibitor) With Micropulse Diode Laser Treatment in a Randomized, Controlled Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02059772
- Acronym / sponsor ID
- ReCaLL / ReCaLL-2013
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 11 Feb 2014 (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 primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Drug: ranibizumabStandard therapy of diabetic macular edema with Lucentis (ranibizumab) according to SmPC |
| Treatment Group | Experimental | Drug: ranibizumab, Procedure: micropulse diode laserCombination of standard therapy of Lucentis (ranibizumab) according to SmPC and micropulse diode laser treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of non-ischemic diabetic macular edema with resulting reduction in visual functionality by determination of best corrected visual acuity (BCVA), ophthalmologic investigation, SD-OCT, FAG and anamnesis
- BCVA between 0.05 and 0.6 or retinal thickness > 300 µm determined by SD-OCT
- The informed consent form must be signed before any study specific tests or procedures are done
- Confirmation of the subject's health insurance coverage prior to the first screening visit
- Age at least 18 years (inclusive) at the first screening visit
Key exclusion criteria (16 listed)
- Severe ischemic maculopathy of the study eye
- Active neovascularization of iris or retina in the study eye
- History of intravitreal injection of VEGF-inhibitor or steroids in study eye within the last 3 month
- Pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract)
- Advanced glaucoma with central defects of the visual field in study eye
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 |
|---|---|---|
| ranibizumabAlso: Lucentis | Drug | Control Group, Treatment Group |
| micropulse diode laser | Procedure or surgery | Treatment Group |
Primary outcome
change in best corrected visual acuity (BCVA)
Time frame: baseline, 12 month
2 secondary outcomes
change in central macular thickness
Time frame: baseline, 12 month
number of intravitreal Lucentis injections
Time frame: within 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 32727496Furashova O, Strassburger P, Becker KA, Engelmann K. Efficacy of combining intravitreal injections of ranibizumab with micropulse diode laser versus intravitreal injections of ranibizumab alone in diabetic macular edema (ReCaLL): a single center, randomised, controlled, non-inferiority clinical trial. BMC Ophthalmol. 2020 Jul 29;20(1):308. doi: 10.1186/s12886-020-01576-w.
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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.
Klio Ai Becker, MD study chair
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 and micropulse diode laser in people with Diabetic Macular Edema, run by GWT-TUD GmbH 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. 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 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?
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?
change in best corrected visual acuity (BCVA) (time frame: baseline, 12 month). 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 NCT02059772, 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 23 Feb 2017.