Chronic Central Serous ChorioretinopathyPhase 2NCT00211445
Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)
A Phase 2 study testing Photodynamic Therapy with Verteporfin and verteporfin in people with Chronic Central Serous Chorioretinopathy, run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
Trial summary
Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by exudation of fluid under the retina localized to the posterior pole as well as loss of vision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Central Serous Chorioretinopathy
- What is being tested?
- Photodynamic Therapy with Verteporfin and verteporfin
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Jan 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of chronic central serous chorioretinopathy and clinical/angiographic findings typical of the disease of greater than 6 months duration.Chronic central serous chorioretinopathy could be defined on the basis of two factors: a) persistence of the detachment for more than 6 months and b) chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium.
- VA 20/40 and 20/320 Study Eye on the ETDRS visual acuity chart.
- VA 20/800 or better Fellow Eye on the ETDRS visual acuity chart.
Who cannot join
- Patient with tears in retinal pigment epithelium.
- Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye.
- Patient participating in any other investigational drug study.
- Inability to obtain photographs to document CNV (including difficulty with venous access).
- Patient with significant liver disease or uremia.
Show all 9Show fewer
- Patient with known adverse reaction to indocyanine green or iodine.
- Patient is pregnant or nursing
- Age less than 18 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Eye, Ear & Throat Hospital
New York, New York, 10021
About this study
Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by exudation of fluid under the retina localized to the posterior pole as well as loss of vision. The etiology is unknown, but according to the studies this condition is more common in young males and is associated with type A personality. Clinically, CSC is characterized by serous retinal detachment and area of leakage of in the subretinal space. The standard of care for acute CSC is observation for a period of up to 3 months. If there is no complete resolution of the retinal detachment by 3 months, there is an indication for focal laser photocoagulation therapy of the area of leakage. This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of detachment. However, laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because there is not a single easily identifiable point of leakage but rather diffuse disease of RPE thus rendering laser treatment ineffective.The purpose of this medical research study is to evaluate Verteporfin therapy as an approach which may benefit patients with CSC, based on observations in exudative type of AMD patients treated with Photodynamic Therapy using Verteporfin.
Read the detailed description
7.1 Visit 1 - Screening Visit
The first visit by the patient is for the purpose of screening the patient for the study. This visit must occur within 1 week prior to the treatment visit. At this visit the investigator and the supporting staff will:
- Determine if the patient is eligible for enrollment in the study, explain the study to the patient, and obtain an informed consent from the patient. The form should be witnessed and documented by obtaining the patient's signature at this visit.
- Only one eye of the patient can be enrolled in the study. For patients with lesions in both eyes, the investigator may enroll the eye they deem most eligible or amenable to treatment.
- Record patient demographics, complete medical history and contact information on the initial visit form.
- Perform a complete eye examination including:
- visual acuity. ii. slit-lamp biomicroscopy. iii. dilated fundus examination.
- Obtain stereo color fundus photographs (30 degree field of view) of the study eye.
- Obtain sodium fluorescein angiogram of the study eye via digital imaging system.
- Obtain ICGA of the study eye. NOTE: If a patient presents with any acute illness during screening and the day of treatment administration, his entry into the study is deferred until the acute illness resolves.
7.2 Visit 2 - Treatment Visit (Day Zero)
At this visit the patient is assigned a Verteporfin-PDT laser energy delivery profile according to the scheme detailed in Section 5.1, above. The investigator and the supporting staff will:
- Perform an eye examination including best-corrected visual acuity using the EDTRS visual chart.
- The angiograms may need to be repeated if the previous angiograms were done more than 72 hours ago.
- Perform Verteporfin-PDT treatment. NOTE: If a patient presents with any acute illness during screening and the day of treatment administration, his entry into the study is deferred till the acute illness resolves.
7.3 Visit 3 \& 4- First Post-treatment Follow-up Visit
The investigator will have the patient return to the office after 2 weeks (Visit 3) and 6 weeks (Visit 4) after performing the Verteporfin-PDT treatment. At this visit the investigator and the supporting staff will:
- Perform a complete eye examination including
- best corrected visual acuity using EDTRS visual acuity chart.
- slit-lamp biomicroscopy.
- dilated fundus examination.
- Obtain stereo color fundus photographs (30 degree field of view) of the study eye.
- Obtain sodium fluorescein angiogram of the study eye via digital imaging system.
- Obtain ICGA of the study eye.
- Ask the patient about any new ocular or systemic symptoms that developed since last visit, and look for any associated signs and record both on the case report forms.
- Ask the patient and record any new medications being used since the last visit.
- If the patient is re-treated then the post-treatment visit schedule will start again at visit 3 as detailed in Section 7.3 Visit 3.
7.4 Visit 5 through Visit 12 - Follow-up Visits
The investigator will have the patient return to the office at 3-month (plus/minus 2 weeks) intervals after performing the last Verteporfin-PDT treatment. The visit windows are continuous, but two consecutive visits should not be scheduled within 2 weeks of each other. At these visits the investigator and the supporting staff will:
- Perform a complete eye examination including
- best corrected visual acuity using EDTRS visual acuity chart.
- slit lamp biomicroscopy.
- dilated fundus examination.
- Obtain stereo color fundus photographs (30 degree field of view) of the study eye.
- Obtain sodium fluorescein angiogram of the study eye.
- Obtain ICGA of the study eye.
- Ask the patient about any ocular or systemic symptoms, and look for any associated signs and record both on the case report forms.
- Ask the patient and record any medications being used.
- Based on the eye examination and the ICGA the investigator must decide whether any new or previously treated CNV vessels need to be treated.
- Perform any additional or concomitant treatment as required.
- At the final visit (approximately 24 months after entry into the study), the patient will be terminated from the study.
- Conditions
- Chronic Central Serous Chorioretinopathy
- Being tested
- Photodynamic Therapy with Verteporfin, verteporfin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic Therapy with VerteporfinProcedure or surgery
verteporfinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in VA (ETDRS) from baseline to 24 months
Measured: 24 months
investigate the potential of photodynamic therapy using verteporpin in chronic central serous chorioretinopathy
Measured: 24 months
Secondary outcomes (1)
mean change of VA(ETDRS), OCT, FA from baseline to 24 months
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2002
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Central Serous ChorioretinopathyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Eye, Ear & Throat Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jason S. Slakter, MD, Principal investigator, Manhattan Eye, Ear & Throat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211445
- Sponsor's protocol ID
- PDT for CSC
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2005
- Last updated
- 28 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)
- ClinicalTrials.gov ID
- NCT00211445
- Acronym / sponsor ID
- PDT for CSC
- Conditions
- Chronic Central Serous Chorioretinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Manhattan Eye, Ear & Throat HospitalUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- Jan 2006 (actual)
- First posted
- 21 Sep 2005 (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.
Central serous choroidal (CSC) retinopathy is a disease of the macula characterized by exudation of fluid under the retina localized to the posterior pole as well as loss of vision. The etiology is unknown, but according to the studies this condition is more common in young males and is associated with type A personality. Clinically, CSC is characterized by serous retinal detachment and area of leakage of in the subretinal space. The standard of care for acute CSC is observation for a period of up to 3 months. If there is no complete resolution of the retinal detachment by 3 months, there is an indication for focal laser photocoagulation therapy of the area of leakage. This treatment is usually effective in stopping leakage of fluid under the retina and causing resolution of detachment. However, laser photocoagulation therapy is not beneficial in the treatment of chronic CSC because there is not a single easily identifiable point of leakage but rather diffuse disease of RPE thus rendering laser treatment ineffective.The purpose of this medical research study is to evaluate Verteporfin therapy as an approach which may benefit patients with CSC, based on observations in exudative type of AMD patients treated with Photodynamic Therapy using Verteporfin.
Detailed description
7.1 Visit 1 - Screening Visit
The first visit by the patient is for the purpose of screening the patient for the study. This visit must occur within 1 week prior to the treatment visit. At this visit the investigator and the supporting staff will:
- Determine if the patient is eligible for enrollment in the study, explain the study to the patient, and obtain an informed consent from the patient. The form should be witnessed and documented by obtaining the patient's signature at this visit.
- Only one eye of the patient can be enrolled in the study. For patients with lesions in both eyes, the investigator may enroll the eye they deem most eligible or amenable to treatment.
- Record patient demographics, complete medical history and contact information on the initial visit form.
- Perform a complete eye examination including:
- visual acuity. ii. slit-lamp biomicroscopy. iii. dilated fundus examination.
- Obtain stereo color fundus photographs (30 degree field of view) of the study eye.
- Obtain sodium fluorescein angiogram of the study eye via digital imaging system.
- Obtain ICGA of the study eye. NOTE: If a patient presents with any acute illness during screening and the day of treatment administration, his entry into the study is deferred until the acute illness resolves.
7.2 Visit 2 - Treatment Visit (Day Zero)
At this visit the patient is assigned a Verteporfin-PDT laser energy delivery profile according to the scheme detailed in Section 5.1, above. The investigator and the supporting staff will:
- Perform an eye examination including best-corrected visual acuity using the EDTRS visual chart.
- The angiograms may need to be repeated if the previous angiograms were done more than 72 hours ago.
- Perform Verteporfin-PDT treatment. NOTE: If a patient presents with any acute illness during screening and the day of treatment administration, his entry into the study is deferred till the acute illness resolves.
7.3 Visit 3 \& 4- First Post-treatment Follow-up Visit
The investigator will have the patient return to the office after 2 weeks (Visit 3) and 6 weeks (Visit 4) after performing the Verteporfin-PDT treatment. At this visit the investigator and the supporting staff will:
- Perform a complete eye examination including
- best corrected visual acuity using EDTRS visual acuity chart.
- slit-lamp biomicroscopy.
- dilated fundus examination.
- Obtain stereo color fundus photographs (30 degree field of view) of the study eye.
- Obtain sodium fluorescein angiogram of the study eye via digital imaging system.
- Obtain ICGA of the study eye.
- Ask the patient about any new ocular or systemic symptoms that developed since last visit, and look for any associated signs and record both on the case report forms.
- Ask the patient and record any new medications being used since the last visit.
- If the patient is re-treated then the post-treatment visit schedule will start again at visit 3 as detailed in Section 7.3 Visit 3.
7.4 Visit 5 through Visit 12 - Follow-up Visits
The investigator will have the patient return to the office at 3-month (plus/minus 2 weeks) intervals after performing the last Verteporfin-PDT treatment. The visit windows are continuous, but two consecutive visits should not be scheduled within 2 weeks of each other. At these visits the investigator and the supporting staff will:
- Perform a complete eye examination including
- best corrected visual acuity using EDTRS visual acuity chart.
- slit lamp biomicroscopy.
- dilated fundus examination.
- Obtain stereo color fundus photographs (30 degree field of view) of the study eye.
- Obtain sodium fluorescein angiogram of the study eye.
- Obtain ICGA of the study eye.
- Ask the patient about any ocular or systemic symptoms, and look for any associated signs and record both on the case report forms.
- Ask the patient and record any medications being used.
- Based on the eye examination and the ICGA the investigator must decide whether any new or previously treated CNV vessels need to be treated.
- Perform any additional or concomitant treatment as required.
- At the final visit (approximately 24 months after entry into the study), the patient will be terminated from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Evidence of chronic central serous chorioretinopathy and clinical/angiographic findings typical of the disease of greater than 6 months duration.Chronic central serous chorioretinopathy could be defined on the basis of two factors: a) persistence of the detachment for more than 6 months and b) chronic recurrent acute detachments with widespread decompensation of the retinal pigment epithelium.
- VA 20/40 and 20/320 Study Eye on the ETDRS visual acuity chart.
- VA 20/800 or better Fellow Eye on the ETDRS visual acuity chart.
Key exclusion criteria (9 listed)
- Patient with tears in retinal pigment epithelium.
- Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye.
- Patient participating in any other investigational drug study.
- Inability to obtain photographs to document CNV (including difficulty with venous access).
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 |
|---|---|---|
| Photodynamic Therapy with Verteporfin | Procedure or surgery | – |
| verteporfin | Drug | – |
Primary outcome
mean change in VA (ETDRS) from baseline to 24 months
Time frame: 24 months
investigate the potential of photodynamic therapy using verteporpin in chronic central serous chorioretinopathy
Time frame: 24 months
1 secondary outcome
mean change of VA(ETDRS), OCT, FA from baseline to 24 months
Time frame: 2 years
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 28 Sep 2007.
Related trials for Chronic Central Serous Chorioretinopathy
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Central Serous Chorioretinopathy (CSC)
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.
Jason S. Slakter, MD principal investigator
Manhattan Eye, Ear & Throat Hospital
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 Photodynamic Therapy with Verteporfin and verteporfin in people with Chronic Central Serous Chorioretinopathy, run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
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 9 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 28 Sep 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 United States. 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?
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?
mean change in VA (ETDRS) from baseline to 24 months (time frame: 24 months). 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 28 Sep 2007.