Maculopathy, Age-RelatedPhase 2NCT00331253
Treatment of Patients With Neovascular AMD Using Indocyanine Green-Mediated Photothrombosis (i-MP).
A Phase 2 study testing Indocyanine Green-Mediated Photothrombosis in people with Maculopathy, Age-Related, run by Opto Eletronica S.A. at 1 site in Brazil.
Trial summary
To establish the safety and efficacy of indocyanine green-mediated photothrombosis (i-MP) for the treatment of patients with neovascular age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Maculopathy, Age-Related
- What is being tested?
- Indocyanine Green-Mediated Photothrombosis
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2007to Dec 2008
- Phase
- Phase 2
- 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
- Age over 50 years;
- Presence of at least 1 soft drusen in the macular region, associated or not to pigment alterations (hyper- or hypo-pigmentation), thus characterising AMD;
- Reduction of vision due exclusively to macular exudative processes resulting from the formation of associated choroidal neovascularisation (neovascular AMD);
- Patients presenting:
- Neovascular complexes characterised by presence of some occult CNV component in their formation by fluorescein angiography and BCVA worse than 20/80, OR;
- Neovascular complexes with total CNV (classic and occult) area by fluorescein angiography occupying an area lesser than 50% of the neovascular complex and BCVA worse than 20/80, OR;
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- BCVA lesser than 20/200, regardless of the type of composition of the neovascular complex;
- Direct involvement of the avascular foveal zone by the neovascular complex;
- Informed Consent Form in writing and appropriately signed.
Who cannot join
- BCVA lesser than 20/400;
- Greatest linear dimension of the neovascular complex greater than 6000 (six thousand) micron;
- Previous Photodynamic Therapy (PDT);
- Thermal laser for the treatment of any CNV;
- Intra vitreous injection of corticosteroids or anti-angiogenic drugs;
- Opacities of the media that can significantly interfere on the VA, clinical ophthalmic assessment, documentation of the eye fundus and performance of laser therapy;
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- Other causes of CNV such as pathologic myopia (spherical equivalent greater than 6 [six] spherical diopters and/or axial length greater than 26mm), angioid streaks, active uveitis, ocular presumed histoplasmosis and traumatic choroidal rupture;
- CNV associated to serous/sero hemorrhagic RPED (vascular RPED / hemorrhagic RPED);
- Absence of identifiable CNV by fluorescein angiography (massive presence of thick blood);
- CNV with absence of ICG uptake by ICG angiography despite the eligibility of the patient by clinical criteria and fluorescein angiography;
- Intraocular surgery undertaken in the last 3 months;
- Posterior vitrectomy or retinopexy with scleral introflexion, at any time;
- Severe form of non-proliferative Diabetic Retinopathy;
- Acute ocular infection;
- Ionizing radiation treatment on the face, skull and neck region;
- Allergy to fluorescein or indocyanine green;
- Excessive known use of alcohol or drugs;
- Medical or psychological conditions which may impede the patient of completing the study or sing the Informed Consent Form;
- Significant uncontrolled disease which, in the opinion of the investigator, may exclude the patient from the study;
- Impediment or limited legal capability;
- Participation in other clinical study in the last 30 days. NOTE: Patients who have participated of any clinical study in the last 12 months, even though they had finished their participation prior to the last 30 days, will only be eligible to inclusion if the participation in the present protocol will bring clear benefit to the patient.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Goias
Goiânia, Goias/Go, 00000
Avila Marcos, MD, 55-16-3252 5566, retina@cbco.com.br
David Isaac, MD, 55-16-3252 5566, cruvinelisaac@hotmail.com
About this study
Official title: A 54-WEEK, PHASE 2, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INDOCYANINE GREEN-MEDIATED PHOTOTHROMBOSIS (i-MP) FOR THE TREATMENT OF PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.
To establish the safety and efficacy of indocyanine green-mediated photothrombosis (i-MP) for the treatment of patients with neovascular age-related macular degeneration.
Read the detailed description
Comparative, controlled, multicenter, masked, randomized study, three parallel groups, comparing the Indocyanine Green-Mediated Photothrombosis to two control groups, for the treatment of neovascular Age-Related Macular Degeneration.
Only patients matching the following criteria are eligible:
- BCVA worse than 20/80 and neovascular complex with some component of occult CNV as defined by the fluorescein angiography, or; B. BCVA worse than 20/80 and neovascular complex with total area of CNV (classic and occult) by fluorescein angiography occupying an area lesser than 50% of the neovascular complex, or; C. BCVA worse than 20/200 and neovascular complex with some CNV (classic OR occult) by fluorescein angiography.
The eligibility of the patients will be assessed by an independent Centre of Interpretation after masked analysis.
Eligible patients will be allocated into one of the three study groups, randomized at 2:1:1 proportion:
Group 1: Treatment Procedure #1 = i-MP (ICG + Laser), at proportion of 2. In this group the patients will be submitted to endovenous infusion of ICG followed by irradiation with diode laser.
Group 2: Treatment Procedure #2 (Distilled water + Laser), at proportion of 1. In this group the patients will receive endovenous placebo infusion (distilled water) followed by irradiation with diode laser with same power utilized in Group 1.
Group 3: Treatment Procedure #3 (Distilled water + Sham Laser), at proportion of 1. In this group the patients will receive endovenous placebo infusion (distilled water) followed by simulated application of laser.
- Conditions
- Maculopathy, Age-Related
- Being tested
- Indocyanine Green-Mediated Photothrombosis
- Keywords
- Indocyanine Green-Mediated Photothrombosis, Neovascular, Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green-Mediated PhotothrombosisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the groups in respect to proportion of eyes that lost less than 15 letters in ETDRS BCVA from baseline at week-54
Compare the groups in respect to proportion of eyes that did not present any loss in ETDRS BCVA (2 letters change) from baseline at week-54
Secondary outcomes (2)
Compare the groups in respect to mean change in ETDRS BCVA
Compare the groups in respect to neovascular complex activity (size and CNV leaking area)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startApr 2007
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maculopathy, Age-RelatedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- Opto Eletronica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elizeu Ramos, M.S., Study director, Opto Eletrônica S.A.Avila Marcos, MD, Principal investigator, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331253
- Sponsor's protocol ID
- 001/04/i-MP
- Status last verified
- Apr 2007
- First submitted
- 26 May 2006
- Last updated
- 27 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 54-WEEK, PHASE 2, MULTICENTER, MASKED, RANDOMIZED, CONTROLLED TRIAL TO ESTABLISH THE SAFETY AND EFFICACY OF INDOCYANINE GREEN-MEDIATED PHOTOTHROMBOSIS (i-MP) FOR THE TREATMENT OF PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.
- ClinicalTrials.gov ID
- NCT00331253
- Acronym / sponsor ID
- 001/04/i-MP
- Conditions
- Maculopathy, Age-Related
- Keywords
- Indocyanine Green-Mediated Photothrombosis, Neovascular, Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants
- Lead sponsor
- Opto Eletronica S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 29 May 2006 (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.
To establish the safety and efficacy of indocyanine green-mediated photothrombosis (i-MP) for the treatment of patients with neovascular age-related macular degeneration.
Detailed description
Comparative, controlled, multicenter, masked, randomized study, three parallel groups, comparing the Indocyanine Green-Mediated Photothrombosis to two control groups, for the treatment of neovascular Age-Related Macular Degeneration.
Only patients matching the following criteria are eligible:
- BCVA worse than 20/80 and neovascular complex with some component of occult CNV as defined by the fluorescein angiography, or; B. BCVA worse than 20/80 and neovascular complex with total area of CNV (classic and occult) by fluorescein angiography occupying an area lesser than 50% of the neovascular complex, or; C. BCVA worse than 20/200 and neovascular complex with some CNV (classic OR occult) by fluorescein angiography.
The eligibility of the patients will be assessed by an independent Centre of Interpretation after masked analysis.
Eligible patients will be allocated into one of the three study groups, randomized at 2:1:1 proportion:
Group 1: Treatment Procedure #1 = i-MP (ICG + Laser), at proportion of 2. In this group the patients will be submitted to endovenous infusion of ICG followed by irradiation with diode laser.
Group 2: Treatment Procedure #2 (Distilled water + Laser), at proportion of 1. In this group the patients will receive endovenous placebo infusion (distilled water) followed by irradiation with diode laser with same power utilized in Group 1.
Group 3: Treatment Procedure #3 (Distilled water + Sham Laser), at proportion of 1. In this group the patients will receive endovenous placebo infusion (distilled water) followed by simulated application of laser.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age over 50 years;
- Presence of at least 1 soft drusen in the macular region, associated or not to pigment alterations (hyper- or hypo-pigmentation), thus characterising AMD;
- Reduction of vision due exclusively to macular exudative processes resulting from the formation of associated choroidal neovascularisation (neovascular AMD);
- Patients presenting:
- Neovascular complexes characterised by presence of some occult CNV component in their formation by fluorescein angiography and BCVA worse than 20/80, OR;
Key exclusion criteria (21 listed)
- BCVA lesser than 20/400;
- Greatest linear dimension of the neovascular complex greater than 6000 (six thousand) micron;
- Previous Photodynamic Therapy (PDT);
- Thermal laser for the treatment of any CNV;
- Intra vitreous injection of corticosteroids or anti-angiogenic drugs;
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 |
|---|---|---|
| Indocyanine Green-Mediated Photothrombosis | Procedure or surgery | – |
Primary outcome
Compare the groups in respect to proportion of eyes that lost less than 15 letters in ETDRS BCVA from baseline at week-54
Compare the groups in respect to proportion of eyes that did not present any loss in ETDRS BCVA (2 letters change) from baseline at week-54
2 secondary outcomes
Compare the groups in respect to mean change in ETDRS BCVA
Compare the groups in respect to neovascular complex activity (size and CNV leaking area)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
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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.
Elizeu Ramos, M.S. study director
Opto Eletrônica S.A.
Avila Marcos, MD principal investigator
Universidade Federal de Goias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine Green-Mediated Photothrombosis in people with Maculopathy, Age-Related, run by Opto Eletronica S.A. at 1 site in Brazil.
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 9 inclusion and 21 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 27 Apr 2007. 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 Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Elizeu Ramos, M.S. (55 16 33737023, ELIZEU@opto.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the groups in respect to proportion of eyes that lost less than 15 letters in ETDRS BCVA from baseline at week-54. The study lists 2 primary outcomes in all. 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 Apr 2007; AzTrials last refreshed its copy on 8 Nov 2026.