Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)

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Brief Title

Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)


Brief 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. 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:

        1. 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.

        2. 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.

        3. Record patient demographics, complete medical history and contact information on the
           initial visit form.

        4. Perform a complete eye examination including:

           i. visual acuity. ii. slit-lamp biomicroscopy. iii. dilated fundus examination.

        5. Obtain stereo color fundus photographs (30 degree field of view) of the study eye.

        6. Obtain sodium fluorescein angiogram of the study eye via digital imaging system.

        7. 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:

        1. Perform an eye examination including best-corrected visual acuity using the EDTRS visual
           chart.

        2. The angiograms may need to be repeated if the previous angiograms were done more than 72
           hours ago.

        3. 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:

        1. Perform a complete eye examination including

             1. best corrected visual acuity using EDTRS visual acuity chart.

             2. slit-lamp biomicroscopy.

             3. dilated fundus examination.

        2. Obtain stereo color fundus photographs (30 degree field of view) of the study eye.

        3. Obtain sodium fluorescein angiogram of the study eye via digital imaging system.

        4. Obtain ICGA of the study eye.

        5. 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.

        6. Ask the patient and record any new medications being used since the last visit.

        7. 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:

        1. Perform a complete eye examination including

             1. best corrected visual acuity using EDTRS visual acuity chart.

             2. slit lamp biomicroscopy.

             3. dilated fundus examination.

        2. Obtain stereo color fundus photographs (30 degree field of view) of the study eye.

        3. Obtain sodium fluorescein angiogram of the study eye.

        4. Obtain ICGA of the study eye.

        5. Ask the patient about any ocular or systemic symptoms, and look for any associated signs
           and record both on the case report forms.

        6. Ask the patient and record any medications being used.

        7. Based on the eye examination and the ICGA the investigator must decide whether any new
           or previously treated CNV vessels need to be treated.

        8. Perform any additional or concomitant treatment as required.

        9. At the final visit (approximately 24 months after entry into the study), the patient
           will be terminated from the study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

mean change in VA (ETDRS) from baseline to 24 months

Secondary Outcome

 mean change of VA(ETDRS), OCT, FA from baseline to 24 months

Condition

Chronic Central Serous Chorioretinopathy

Intervention

Photodynamic Therapy with Verteporfin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

11

Start Date

July 2002

Completion Date

January 2006


Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. VA 20/40 and 20/320 Study Eye on the ETDRS visual acuity chart.

          3. VA 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

        Exclusion Criteria:

          1. Patient with tears in retinal pigment epithelium.

          2. Patient with significantly compromised visual acuity in the study eye due to
             concomitant ocular conditions.

          3. Patients who have undergone intraocular surgery within last 2 months or capsulotomy
             within last month in study eye.

          4. Patient participating in any other investigational drug study.

          5. Inability to obtain photographs to document CNV (including difficulty with venous
             access).

          6. Patient with significant liver disease or uremia.

          7. Patient with known adverse reaction to indocyanine green or iodine.

          8. Patient is pregnant or nursing

          9. Age less than 18 years old
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jason S. Slakter, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00211445

Organization ID

PDT for CSC



Study Sponsor

Manhattan Eye, Ear & Throat Hospital


Study Sponsor

Jason S. Slakter, MD, Principal Investigator, Manhattan Eye, Ear & Throat Hospital


Verification Date

September 2007