Choroidal NeovascularizationPhase 4NCT03409250
SD-OCT-guided Intravitreal Ranibizumab Treatment in Choroidal Neovascularization Due to Myopia
A Phase 4 study testing Ranibizumab, Lucentis in people with Choroidal Neovascularization and Age Related Macular Degeneration, run by Vista Klinik at 1 site in Switzerland.
Trial summary
This investigator initiated pilot study is designed to investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Choroidal Neovascularization, Age Related Macular Degeneration
- What is being tested?
- Ranibizumab, Lucentis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2011to Jul 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 18 years of age.
- Patients with active primary sub- or juxtafoveal CNV secondary to myopia.
- Evidence that CNV extends under the geometric center of the foveal avascular zone or in case of juxtafoveal lesions there is evidence that leakage from CNV extends under the geometric center of the foveal avascular zone as proven by fluorescein angiography.
- The total area of CNV encompassed within the lesion must be ≥ 50% of the total lesion area.
- The total lesion area ≤ 12 disc areas for minimally classic or occult with no classic component and ≤ 9 disc areas (5400µm) in greatest linear dimension with predominantly classic lesions.
- Patients who have a BCVA of ≥ 20/200 (letter score of ≥ 23 letters) in the study eye using ETDRS charts.
- Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure including withdrawal from exclusionary medications for the purpose of this study.
- Willing and able to comply with study procedures.
Who cannot join
- Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1 disc area in size.
- Structural damage to the center of the macula (beside CNV) in the study eye likely to preclude improvement in visual acuity, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized hard exudate plaques.
- Presence of a retinal pigment epithelial tear involving the macula in the study eye.
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
- Active intraocular inflammation (grade trace or above) in the study eye.
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- Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye.
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
- Aphakia with absence of the posterior capsule in the study eye.
- Any prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, transpupillary thermotherapy, intravitreally applied drugs.
- History of submacular surgery in the study eye, glaucoma filtration surgery, corneal transplant surgery.
- Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.).
- Use of other investigational drugs at the time of baseline, or within 30 days or 5 half- lives of baseline, whichever is longer (excluding vitamins and minerals).
- Previous violation of the posterior capsule in the study eye unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
- History of Stroke.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/ml).
- History of hypersensitivity or allergy to fluorescein.
- Inability to obtain OCTs, fundus photographs or fluorescein angiograms of sufficient quality.
Trial locations and contacts
1 site in 1 country.
About this study
This investigator initiated pilot study is designed to investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of Ranibizumab 0.5mg (Lucentis) at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral-domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
Read the detailed description
Study purpose: This investigator iniiated pilot study is designed to investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of Ranibizumab 0.5mg (Lucentis) at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral-domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
Objectives: To investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia.
The primary objective is to demonstrate that a SD-OCT-guided intravitreal ranibizumab treatment in CNV due to myopia may prevent vision loss as evaluated as change in BCVA from baseline.
The secondary objectives are:
- To evaluate the changes in BCVA at 6 and 12 months compared to baseline.
- To evaluate the number of treatments needed at 6 and 12 months and the time course of re-treatments.
- To evaluate the time course of re-activation of CNV as evaluated by High Resolution OCT.
- To evaluate the incidence of fluorescein leakage as well as the mean and percent change in total area of CNV, total area of leakage from CNV, and total lesion area at 6 and 12 months.
- To evaluate the safety and tolerability of up to monthly dosing of ranibizumab in CNV due to myopia by determining the rates of adverse events and serious adverse events at month 6 and 12.
Population: This outpatient study population will consist of a representative group of male and female patients ≥ 18 years of age. The study population will include patients with newly diagnosed and active choroidal neovascularization (CNV) due to myopia. 20 Patients will be enrolled in one study center (Vista Klinik, Binningen).
Investigational and reference therapy:
This study will include the following study drug:
- Ranibizumab (Lucentis®) 0.5 mg for intravitreal injection.
Study design: This is a prospective, 1-arm, monocenter, investigator initiated study designed to evaluate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of ranibizumab 0.5mg at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT, as defined by intraretinal cysts or subretinal fluid, triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
For this study, a month is defined as 28 days. During the 12-month study period, a maximum of 12 ranibizumab injections may be administered.
- Being tested
- Ranibizumab, Lucentis
- Keywords
- CNV due to Age Related Macular Degeneration
- Medical subject headings
- Choroidal Neovascularization, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab, LucentisDrug
Also called Intravitreal injection with Lucentis (Ranibizumab)
Intravitreal injection with Lucentis (Ranibizumab)
| Study group | Role | What they receive |
|---|---|---|
| 1-Arm study | Other | prospective, 1-arm, monocenter, investigator initiated study Intravitreal injection with Lucentis (Ranibizumab) Receives: Drug: Ranibizumab, Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
SD-OCT-guided intavitreal ranibizumab treatment in CNV due to myopiea may prevent vision loss as evaluated as change in BCVA from Baseline.
Measured: Baseline to 12-months
Secondary outcomes (5)
BCVA change from Baseline to month 12
To evaluate the changes in BCVA at 6 and 12 months compared to baseline.
Measured: Baseline to month 12
Treatments from Baseline to month 12
To evaluate the number of treatments needed at 6 and 12 months and the time course of re-treatments.
Measured: Baseline to month 12
OCT changes from Baseline to month 12
To evaluate the time course of re-activation of CNV as evaluated by High Resolution OCT.
Measured: Baseline to month 12
Fluo changes from Baseline to month 12
To evaluate the incidence of fluorescein leakage as well as the mean and percent change in total area of CNV, total area of leakage from CNV, and total lesion area at 6 and 12 months.
Measured: Baseline to month 12
Ranibizumab tolerability from Baseline to month 12
To evaluate the safety and tolerability of up to monthly dosing of ranibizumab in CNV due to myopia by determining the rates of adverse events and serious adverse events at month 6 and 12.
Measured: Baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study startJun 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vista Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Katja Hatz, Vista Klinik
- Investigators
- Christian Pruente, MD, Principal investigator, Vista Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409250
- Sponsor's protocol ID
- MYOPIE-2011-04
- Status last verified
- Jan 2018
- First submitted
- 25 Nov 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SD-OCT-guided Intravitreal Ranibizumab Treatment in Choroidal Neovascularization Due to Myopia
- ClinicalTrials.gov ID
- NCT03409250
- Acronym / sponsor ID
- MYOPIE-2011-04
- Keywords
- CNV due to Age Related Macular Degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vista KlinikUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Jan 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.
This investigator initiated pilot study is designed to investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of Ranibizumab 0.5mg (Lucentis) at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral-domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
Detailed description
Study purpose: This investigator iniiated pilot study is designed to investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of Ranibizumab 0.5mg (Lucentis) at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral-domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
Objectives: To investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia.
The primary objective is to demonstrate that a SD-OCT-guided intravitreal ranibizumab treatment in CNV due to myopia may prevent vision loss as evaluated as change in BCVA from baseline.
The secondary objectives are:
- To evaluate the changes in BCVA at 6 and 12 months compared to baseline.
- To evaluate the number of treatments needed at 6 and 12 months and the time course of re-treatments.
- To evaluate the time course of re-activation of CNV as evaluated by High Resolution OCT.
- To evaluate the incidence of fluorescein leakage as well as the mean and percent change in total area of CNV, total area of leakage from CNV, and total lesion area at 6 and 12 months.
- To evaluate the safety and tolerability of up to monthly dosing of ranibizumab in CNV due to myopia by determining the rates of adverse events and serious adverse events at month 6 and 12.
Population: This outpatient study population will consist of a representative group of male and female patients ≥ 18 years of age. The study population will include patients with newly diagnosed and active choroidal neovascularization (CNV) due to myopia. 20 Patients will be enrolled in one study center (Vista Klinik, Binningen).
Investigational and reference therapy:
This study will include the following study drug:
- Ranibizumab (Lucentis®) 0.5 mg for intravitreal injection.
Study design: This is a prospective, 1-arm, monocenter, investigator initiated study designed to evaluate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of ranibizumab 0.5mg at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT, as defined by intraretinal cysts or subretinal fluid, triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.
For this study, a month is defined as 28 days. During the 12-month study period, a maximum of 12 ranibizumab injections may be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1-Arm study | Other | Drug: Ranibizumab, Lucentisprospective, 1-arm, monocenter, investigator initiated study Intravitreal injection with Lucentis (Ranibizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients ≥ 18 years of age.
- Patients with active primary sub- or juxtafoveal CNV secondary to myopia.
- Evidence that CNV extends under the geometric center of the foveal avascular zone or in case of juxtafoveal lesions there is evidence that leakage from CNV extends under the geometric center of the foveal avascular zone as proven by fluorescein angiography.
- The total area of CNV encompassed within the lesion must be ≥ 50% of the total lesion area.
- The total lesion area ≤ 12 disc areas for minimally classic or occult with no classic component and ≤ 9 disc areas (5400µm) in greatest linear dimension with predominantly classic lesions.
Key exclusion criteria (19 listed)
- Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1 disc area in size.
- Structural damage to the center of the macula (beside CNV) in the study eye likely to preclude improvement in visual acuity, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized hard exudate plaques.
- Presence of a retinal pigment epithelial tear involving the macula in the study eye.
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the 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 |
|---|---|---|
| Ranibizumab, LucentisAlso: Intravitreal injection with Lucentis (Ranibizumab)Intravitreal injection with Lucentis (Ranibizumab) | Drug | 1-Arm study |
Primary outcome
BCVA
Time frame: Baseline to 12-months
SD-OCT-guided intavitreal ranibizumab treatment in CNV due to myopiea may prevent vision loss as evaluated as change in BCVA from Baseline.
5 secondary outcomes
BCVA change from Baseline to month 12
Time frame: Baseline to month 12
Treatments from Baseline to month 12
Time frame: Baseline to month 12
OCT changes from Baseline to month 12
Time frame: Baseline to month 12
Fluo changes from Baseline to month 12
Time frame: Baseline to month 12
Ranibizumab tolerability from Baseline to month 12
Time frame: Baseline to month 12
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 1 Feb 2018.
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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.
Christian Pruente, MD principal investigator
Vista Klinik
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, Lucentis in people with Choroidal Neovascularization and Age Related Macular Degeneration, run by Vista Klinik 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 8 inclusion and 19 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 1 Feb 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 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 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?
BCVA (time frame: Baseline to 12-months). 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 1 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.