Geographic AtrophyMPL4DRYNCT01799564
Micropulse Laser for Geographic Atrophy
A study testing Micropulse in people with Geographic Atrophy and Age-related Macular Degeneration, run by Institut de la Macula y la Retina at 1 site in Spain.
Trial summary
Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy, Age-related Macular Degeneration
- What is being tested?
- Micropulse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2012to 27 Nov 2013
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GA > 0.5 disk areas secondary to AMD in both eyes
- 50 years or older
- The periphery of the atrophic lesions must demonstrate increased autofluorescence
- Best corrected visual acuity between 20/20 and 20/400 inclusive
- Clear ocular media
- Ability to provide informed consent and attend all study visits
Who cannot join
- GA secondary to other causes aside from AMD
- Evidence of choroidal neovascularization in either eye
- Any prior treatment for AMD, aside from antioxidants
- Any other ocular condition that would progress in the study period and confound visual acuity assessment
- Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve
- Presence of idiopathic or autoimmune-associated uveitis
Show all 11Show fewer
- Any intraocular surgery 3 months of entry
- Any prior thermal laser in the macula
- History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery
- Previous therapeutic radiation in the ocular region in either eye
- Any treatment with an investigational agent in the previous 60 days before study entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Establish the Safety and Efficacy of Retinal Pigment Epithelium Micropulse Laser in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further vision loss.
- Being tested
- Micropulse
- Keywords
- Geographic atrophy, Age-related macular degeneration, Fundus autofluorescence
- Medical subject headings
- Geographic Atrophy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicropulseProcedure or surgery
Between 1 and 3 sessions of micropulse laser will be applied in the inferior hemiretina of the randomly selected eye
| Study group | Role | What they receive |
|---|---|---|
| Micropulse | Experimental | Micropulse laser will be applied to the inferior hemiretina next to the area of atrophy in a randomly selected eye in 1, 2 or 3 occasions Receives: Procedure: Micropulse |
| Control | No intervention | The fellow eye does not receive any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in area of atrophy as measured with fundus autofluorescence (FAF)
Difference in baseline area of atrophy as measured with FAF at week 48
Measured: Change in area from baseline to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startAug 2012
- Primary completion27 Nov 2013
- Study completion27 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de la Macula y la Retina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Mones MD PhD, Institut de la Macula y la Retina
- Investigators
- Jordi Monés, MD, PhD, Principal investigator, Institut de la màcula i de la retina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799564
- Sponsor's protocol ID
- MPL4DRY
- Acronym
- MPL4DRY
- Status last verified
- Sep 2019
- First submitted
- 25 Feb 2013
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Establish the Safety and Efficacy of Retinal Pigment Epithelium Micropulse Laser in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01799564
- Acronym / sponsor ID
- MPL4DRY / MPL4DRY
- Keywords
- Geographic atrophy, Age-related macular degeneration, Fundus autofluorescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Institut de la Macula y la RetinaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- 27 Nov 2013 (actual)
- Study completion
- 27 Nov 2013 (actual)
- First posted
- 27 Feb 2013 (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.
Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further vision loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropulse | Experimental | Procedure: MicropulseMicropulse laser will be applied to the inferior hemiretina next to the area of atrophy in a randomly selected eye in 1, 2 or 3 occasions |
| Control | No intervention | –The fellow eye does not receive any treatment |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- GA > 0.5 disk areas secondary to AMD in both eyes
- 50 years or older
- The periphery of the atrophic lesions must demonstrate increased autofluorescence
- Best corrected visual acuity between 20/20 and 20/400 inclusive
- Clear ocular media
Key exclusion criteria (11 listed)
- GA secondary to other causes aside from AMD
- Evidence of choroidal neovascularization in either eye
- Any prior treatment for AMD, aside from antioxidants
- Any other ocular condition that would progress in the study period and confound visual acuity assessment
- Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve
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 |
|---|---|---|
| MicropulseBetween 1 and 3 sessions of micropulse laser will be applied in the inferior hemiretina of the randomly selected eye | Procedure or surgery | Micropulse |
Primary outcome
Change in area of atrophy as measured with fundus autofluorescence (FAF)
Time frame: Change in area from baseline to week 48
Difference in baseline area of atrophy as measured with FAF at week 48
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 Sep 2019.
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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.
Jordi Monés, MD, PhD principal investigator
Institut de la màcula i de la retina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropulse in people with Geographic Atrophy and Age-related Macular Degeneration, run by Institut de la Macula y la Retina at 1 site in Spain.
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 11 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 Sep 2019. 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 Spain. 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.
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?
Change in area of atrophy as measured with fundus autofluorescence (FAF) (time frame: Change in area from baseline to week 48). 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 Sep 2019.