- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211445
Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)
Study Overview
Status
Conditions
Intervention / Treatment
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:
i. 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Manhattan Eye, Ear & Throat Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Patient with known adverse reaction to indocyanine green or iodine.
- Patient is pregnant or nursing
- Age less than 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean change in VA (ETDRS) from baseline to 24 months
Time Frame: 24 months
|
24 months
|
investigate the potential of photodynamic therapy using verteporpin in chronic central serous chorioretinopathy
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean change of VA(ETDRS), OCT, FA from baseline to 24 months
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jason S. Slakter, MD, Manhattan Eye, Ear & Throat Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDT for CSC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Central Serous Chorioretinopathy
-
Radboud University Medical CenterOogziekenhuis RotterdamRecruitingChronic Central Serous ChorioretinopathyNetherlands
-
Radboud University Medical CenterUniversity of Oxford; University of Cologne; Leiden University Medical Center; University...CompletedChronic Central Serous ChorioretinopathyNetherlands, France, Germany, United Kingdom
-
Università degli Studi di BresciaUnknownChronic Central Serous Chorioretinopathy
-
Manhattan Eye, Ear & Throat HospitalLuEsther T. Mertz Retinal Research CenterCompletedChronic Central Serous ChorioretinopathyUnited States
-
Ankara Universitesi TeknokentCompletedCentral Serous Chorioretinopathy | Chronic Central Serous ChorioretinopathyTurkey
-
Leiden University Medical CenterRadboud University Medical Center; Academisch Medisch Centrum - Universiteit...UnknownChronic Central Serous ChorioretinopathyNetherlands
-
Manhattan Eye, Ear & Throat HospitalAlcon Research; LuEsther T. Mertz Retinal Research CenterCompletedChronic Central Serous ChorioretinopathyUnited States
-
Semmelweis UniversityCompletedChronic Central Serous ChorioretinopathyHungary
-
Jang Won HeoNovartis Korea Ltd.CompletedChronic Central Serous ChorioretinopathyKorea, Republic of
-
Surugadai Nihon University HospitalTeikyo UniversityCompletedChronic Central Serous ChorioretinopathyJapan
Clinical Trials on Photodynamic Therapy with Verteporfin
-
Ophthalmic PDT Study GroupCompleted
-
Chonnam National University HospitalCompletedCorneal Neovascularization
-
Eyetech PharmaceuticalsPfizerTerminatedAge-Related Macular DegenerationUnited States
-
University of British ColumbiaCompleted
-
California Retina ConsultantsNovartisCompletedMacular Edema | Age Related Macular Degeneration | Choroidal NeovascularizationUnited States
-
Instituto Universitario de Oftalmobiología Aplicada...Fondo de Investigacion SanitariaCompletedChoroidal Neovascularization | MyopiaSpain
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Not yet recruitingPort-Wine Stain | Nevus Flammeus | Port-wine Birthmark
-
Mansoura UniversityEnrolling by invitationPhotodynamic TherapyEgypt
-
Rogers Sciences Inc.Unknown
-
STEBA FranceTerminated