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.
