Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211445
Status:
COMPLETED
Last Update Posted:
2007-09-28
First Post:
2005-09-13
Brief Title:
Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy CSC
Sponsor:
Manhattan Eye Ear Throat Hospital
Organization:
Manhattan Eye Ear Throat Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ineffectiveThe 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:
71 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 patients 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
72 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 51 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
73 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 73 Visit 3
74 Visit 5 through Visit 12 - Follow-up Visits
The investigator will have the patient return to the office at 3-month plusminus 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
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 patients 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
72 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 51 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
73 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 73 Visit 3
74 Visit 5 through Visit 12 - Follow-up Visits
The investigator will have the patient return to the office at 3-month plusminus 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None